Trial Outcomes & Findings for Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) (NCT NCT01524783)
NCT ID: NCT01524783
Last Updated: 2021-08-05
Results Overview
PFS is defined as the time from randomization to the date of the first documented tumor progression or death from any cause, whichever comes first. Progression was defined using modified RECIST 1.0 and as per central radiology assessment as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Progression was assessed by cat scan (CT) and/or magnetic resonance imaging (MRI). For participants who had not progressed or died at the analysis cut-off date, PFS was censored at the date of the last adequate tumor evaluation date. An adequate tumour assessment is a tumour assessment with an overall response other than unknown. The percentage event-free probability estimate is the estimated probability that a patient will remain event-free in PFS up to the specified time point.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
From date of randomization to progression or death, whichever comes first, assessed up to 27 months
Results posted on
2021-08-05
Participant Flow
At baseline, participants were randomized to either everolimus+BSC or placebo+BSC arm. Two patients randomized to the everolimus arm were not treated due to withdrawal of consent and protocol deviation. As per Data Monitoring Committee recommendation (03-Jun-2015), implemented through protocol amendment 3 (issued on 06-May-2016), remaining participants entered the open-label part of the study, where participants in the placebo arm were allowed to crossover to open-label treatment with everolimus
Participant milestones
| Measure |
Everolimus + BSC (Throughout Study)
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo+BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
Everolimus+BSC (Crossover)
Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC
|
|---|---|---|---|
|
Blinded Period
STARTED
|
205
|
97
|
0
|
|
Blinded Period
COMPLETED
|
26
|
6
|
0
|
|
Blinded Period
NOT COMPLETED
|
179
|
91
|
0
|
|
Open-label Period
STARTED
|
26
|
0
|
6
|
|
Open-label Period
COMPLETED
|
0
|
0
|
0
|
|
Open-label Period
NOT COMPLETED
|
26
|
0
|
6
|
Reasons for withdrawal
| Measure |
Everolimus + BSC (Throughout Study)
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo+BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
Everolimus+BSC (Crossover)
Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC
|
|---|---|---|---|
|
Blinded Period
Adverse Event
|
64
|
7
|
0
|
|
Blinded Period
Disease Progression
|
89
|
75
|
0
|
|
Blinded Period
Withdrawal by Subject
|
19
|
6
|
0
|
|
Blinded Period
Protocol deviation
|
2
|
1
|
0
|
|
Blinded Period
Death
|
5
|
2
|
0
|
|
Open-label Period
Disease progression
|
13
|
0
|
2
|
|
Open-label Period
Administrative problems
|
5
|
0
|
2
|
|
Open-label Period
Adverse Event
|
5
|
0
|
1
|
|
Open-label Period
Withdrawal by Subject
|
2
|
0
|
1
|
|
Open-label Period
Protocol deviation
|
1
|
0
|
0
|
Baseline Characteristics
Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)
Baseline characteristics by cohort
| Measure |
Everolimus + BSC
n=205 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo+BSC
n=97 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 12.89 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
162 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
32 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to progression or death, whichever comes first, assessed up to 27 monthsPopulation: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
PFS is defined as the time from randomization to the date of the first documented tumor progression or death from any cause, whichever comes first. Progression was defined using modified RECIST 1.0 and as per central radiology assessment as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Progression was assessed by cat scan (CT) and/or magnetic resonance imaging (MRI). For participants who had not progressed or died at the analysis cut-off date, PFS was censored at the date of the last adequate tumor evaluation date. An adequate tumour assessment is a tumour assessment with an overall response other than unknown. The percentage event-free probability estimate is the estimated probability that a patient will remain event-free in PFS up to the specified time point.
Outcome measures
| Measure |
Everolimus + BSC
n=205 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
n=97 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
4 months
|
81.2 Percent event-free probability in PFS
Interval 74.9 to 86.2
|
49.1 Percent event-free probability in PFS
Interval 38.1 to 59.2
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
6 months
|
72.1 Percent event-free probability in PFS
Interval 65.0 to 78.0
|
40.1 Percent event-free probability in PFS
Interval 29.5 to 50.5
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
2 months
|
90.1 Percent event-free probability in PFS
Interval 84.8 to 93.5
|
74.6 Percent event-free probability in PFS
Interval 64.3 to 82.4
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
8 months
|
62.4 Percent event-free probability in PFS
Interval 54.8 to 69.1
|
35.8 Percent event-free probability in PFS
Interval 25.4 to 46.2
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
21 months
|
27.6 Percent event-free probability in PFS
Interval 19.0 to 36.8
|
17.4 Percent event-free probability in PFS
Interval 9.0 to 28.2
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
24 months
|
22.0 Percent event-free probability in PFS
Interval 13.0 to 32.5
|
17.4 Percent event-free probability in PFS
Interval 9.0 to 28.2
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
27 months
|
NA Percent event-free probability in PFS
Not estimable due to the low number of events
|
17.4 Percent event-free probability in PFS
Interval 9.0 to 28.2
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
10 months
|
51.7 Percent event-free probability in PFS
Interval 44.0 to 59.0
|
31.3 Percent event-free probability in PFS
Interval 21.3 to 41.7
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
12 months
|
44.4 Percent event-free probability in PFS
Interval 36.7 to 51.8
|
28.1 Percent event-free probability in PFS
Interval 18.5 to 38.6
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
15 months
|
40.1 Percent event-free probability in PFS
Interval 32.5 to 47.6
|
26.4 Percent event-free probability in PFS
Interval 16.9 to 36.8
|
—
|
—
|
|
Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
18 months
|
31.8 Percent event-free probability in PFS
Interval 24.1 to 39.8
|
24.4 Percent event-free probability in PFS
Interval 15.0 to 34.9
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of randomization to date of death, assessed up to approximately 8 yearsPopulation: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
OS is defined as the time from the date of randomization to date of death due to any cause. If a death had not been observed by the date of analysis cut-off, then OS was censored at the date of last contact. All participants randomized to placebo arm who crossed over to everolimus were censored.
Outcome measures
| Measure |
Everolimus + BSC
n=205 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
n=97 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
43.1 Months
Interval 36.27 to 54.24
|
41.76 Months
Interval 23.46 to 53.75
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until end of treatment, assessed up to approximately 2.5 yearsPopulation: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
ORR is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), according to central evaluation and as per modified RECIST 1.0. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.
Outcome measures
| Measure |
Everolimus + BSC
n=205 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
n=97 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) as Per Modified RECIST 1.0 According to Central Evaluation
|
2.0 Percentage of participants
Interval 0.5 to 4.9
|
1.0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until end of treatment, assessed up to approximately 2.5 yearsPopulation: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
DCR is defined as the proportion of subjects with best overall response of CR or PR or stable disease based on modified RECIST 1.0 and as per central radiology assessment. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Stable disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.
Outcome measures
| Measure |
Everolimus + BSC
n=205 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
n=97 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
Disease Control Rate (DCR) Based on Modified RECIST 1.0 and as Per Central Radiology Assessment
|
82.4 Percentage of participants
Interval 76.5 to 87.4
|
64.9 Percentage of participants
Interval 54.6 to 74.4
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to definitive deterioration of FACT-G total score, assessed up to approximately 3 yearsPopulation: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions examining physical, social/family, emotional, and functional well-being. Participants responded to the items on a five-point scale, ranging from 0: "Not at all" to 4: "Very much." The total score ranges from 0 to 108, with higher scores indicating a better patient-reported outcome/quality of life. Definitive deterioration is defined as a decrease in the total score by at least 7 points compared to baseline with no further improvement. Death was considered as worsening of the FACT-G total score if it occurred close to the last available assessment, where "close" was defined as twice the planned period between two assessments. Patients without definitive worsening prior to analysis cut-off or prior to start of another anticancer therapy were censored at the date of their last assessment.
Outcome measures
| Measure |
Everolimus + BSC
n=205 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
n=97 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
Time to Definitive Deterioration in Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire Total Score
|
13.01 Months
Interval 9.33 to 24.8
|
9.23 Months
Interval 5.52 to 28.62
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (every 4 weeks) up to 116 weeksPopulation: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints.
CgA is a potential biomarker for tumor response. Blood samples were collected for assessment of CgA levels. Change from Baseline at a particular visit was calculated as the CgA level at that visit minus Baseline.
Outcome measures
| Measure |
Everolimus + BSC
n=205 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
n=97 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 4
|
434.8 microgram/liter (ug/L)
Standard Deviation 2306.70
|
1154.3 microgram/liter (ug/L)
Standard Deviation 9083.39
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 8
|
162.3 microgram/liter (ug/L)
Standard Deviation 2550.65
|
2697.6 microgram/liter (ug/L)
Standard Deviation 19956.90
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 12
|
396.7 microgram/liter (ug/L)
Standard Deviation 2401.78
|
1176.0 microgram/liter (ug/L)
Standard Deviation 3322.13
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 16
|
263.5 microgram/liter (ug/L)
Standard Deviation 2946.76
|
1450.4 microgram/liter (ug/L)
Standard Deviation 4825.78
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 20
|
162.1 microgram/liter (ug/L)
Standard Deviation 2464.47
|
3640.1 microgram/liter (ug/L)
Standard Deviation 12653.42
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 24
|
253.2 microgram/liter (ug/L)
Standard Deviation 3487.27
|
1783.9 microgram/liter (ug/L)
Standard Deviation 5399.98
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 28
|
587.2 microgram/liter (ug/L)
Standard Deviation 4861.35
|
1350.3 microgram/liter (ug/L)
Standard Deviation 5701.70
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 32
|
508.5 microgram/liter (ug/L)
Standard Deviation 6102.61
|
2000.7 microgram/liter (ug/L)
Standard Deviation 6362.83
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 36
|
94.7 microgram/liter (ug/L)
Standard Deviation 4905.17
|
180.9 microgram/liter (ug/L)
Standard Deviation 383.93
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 40
|
511.4 microgram/liter (ug/L)
Standard Deviation 6180.67
|
207.6 microgram/liter (ug/L)
Standard Deviation 403.30
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 44
|
552.8 microgram/liter (ug/L)
Standard Deviation 4173.44
|
140.6 microgram/liter (ug/L)
Standard Deviation 328.02
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 48
|
1326.2 microgram/liter (ug/L)
Standard Deviation 8718.92
|
129.0 microgram/liter (ug/L)
Standard Deviation 326.69
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 52
|
1196.2 microgram/liter (ug/L)
Standard Deviation 7737.76
|
124.2 microgram/liter (ug/L)
Standard Deviation 452.38
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 56
|
1920.6 microgram/liter (ug/L)
Standard Deviation 11250.07
|
134.9 microgram/liter (ug/L)
Standard Deviation 346.33
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 60
|
1722.0 microgram/liter (ug/L)
Standard Deviation 13155.03
|
120.9 microgram/liter (ug/L)
Standard Deviation 415.73
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 64
|
3811.0 microgram/liter (ug/L)
Standard Deviation 26656.45
|
141.6 microgram/liter (ug/L)
Standard Deviation 281.38
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 68
|
1413.3 microgram/liter (ug/L)
Standard Deviation 9588.68
|
222.6 microgram/liter (ug/L)
Standard Deviation 333.93
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 72
|
239.5 microgram/liter (ug/L)
Standard Deviation 2318.79
|
233.7 microgram/liter (ug/L)
Standard Deviation 400.43
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 76
|
3256.5 microgram/liter (ug/L)
Standard Deviation 19395.40
|
210.9 microgram/liter (ug/L)
Standard Deviation 522.62
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 80
|
5421.0 microgram/liter (ug/L)
Standard Deviation 32471.22
|
286.3 microgram/liter (ug/L)
Standard Deviation 425.45
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 84
|
4379.9 microgram/liter (ug/L)
Standard Deviation 28302.84
|
175.4 microgram/liter (ug/L)
Standard Deviation 575.98
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 88
|
571.2 microgram/liter (ug/L)
Standard Deviation 2694.44
|
-9.4 microgram/liter (ug/L)
Standard Deviation 473.66
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 92
|
765.5 microgram/liter (ug/L)
Standard Deviation 2913.15
|
63.7 microgram/liter (ug/L)
Standard Deviation 477.53
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 96
|
984.6 microgram/liter (ug/L)
Standard Deviation 3379.28
|
146.5 microgram/liter (ug/L)
Standard Deviation 468.24
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 100
|
935.3 microgram/liter (ug/L)
Standard Deviation 2961.60
|
-12.7 microgram/liter (ug/L)
Standard Deviation 399.25
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 104
|
1466.4 microgram/liter (ug/L)
Standard Deviation 4257.03
|
-21.7 microgram/liter (ug/L)
Standard Deviation 285.99
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 108
|
2245.8 microgram/liter (ug/L)
Standard Deviation 6077.99
|
215.9 microgram/liter (ug/L)
Standard Deviation 293.87
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 112
|
2817.0 microgram/liter (ug/L)
Standard Deviation 7786.28
|
514.5 microgram/liter (ug/L)
Standard Deviation 661.80
|
—
|
—
|
|
Change From Baseline in Chromogranin A (CgA) Levels
Week 116
|
2951.8 microgram/liter (ug/L)
Standard Deviation 6745.06
|
99.6 microgram/liter (ug/L)
Standard Deviation 92.91
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (every 4 weeks) up to Week 116Population: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints.
NSE is a potential biomarker for tumor response. Blood samples were collected for assessment of NSE levels. Change from Baseline at a particular visit was calculated as the NSE level at that visit minus Baseline.
Outcome measures
| Measure |
Everolimus + BSC
n=205 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
n=97 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 104
|
2.9 microgram/liter (ug/L)
Standard Deviation 4.11
|
-1.7 microgram/liter (ug/L)
Standard Deviation 4.76
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 60
|
2.4 microgram/liter (ug/L)
Standard Deviation 8.19
|
0.1 microgram/liter (ug/L)
Standard Deviation 3.35
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 64
|
4.4 microgram/liter (ug/L)
Standard Deviation 23.22
|
0.9 microgram/liter (ug/L)
Standard Deviation 3.80
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 68
|
1.1 microgram/liter (ug/L)
Standard Deviation 4.68
|
1.9 microgram/liter (ug/L)
Standard Deviation 4.48
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 72
|
1.6 microgram/liter (ug/L)
Standard Deviation 4.46
|
0.7 microgram/liter (ug/L)
Standard Deviation 3.91
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 76
|
1.7 microgram/liter (ug/L)
Standard Deviation 5.11
|
0.6 microgram/liter (ug/L)
Standard Deviation 3.89
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 4
|
0.1 microgram/liter (ug/L)
Standard Deviation 5.21
|
-2.2 microgram/liter (ug/L)
Standard Deviation 39.87
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 8
|
0.3 microgram/liter (ug/L)
Standard Deviation 8.71
|
-4.2 microgram/liter (ug/L)
Standard Deviation 36.71
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 12
|
-0.3 microgram/liter (ug/L)
Standard Deviation 8.37
|
15.5 microgram/liter (ug/L)
Standard Deviation 163.75
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 16
|
2.0 microgram/liter (ug/L)
Standard Deviation 8.34
|
4.1 microgram/liter (ug/L)
Standard Deviation 19.44
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 20
|
0.8 microgram/liter (ug/L)
Standard Deviation 6.21
|
5.3 microgram/liter (ug/L)
Standard Deviation 18.26
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 24
|
1.7 microgram/liter (ug/L)
Standard Deviation 8.99
|
6.7 microgram/liter (ug/L)
Standard Deviation 23.47
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 28
|
1.1 microgram/liter (ug/L)
Standard Deviation 6.37
|
0.4 microgram/liter (ug/L)
Standard Deviation 9.16
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 32
|
1.5 microgram/liter (ug/L)
Standard Deviation 14.24
|
3.1 microgram/liter (ug/L)
Standard Deviation 8.96
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 36
|
2.0 microgram/liter (ug/L)
Standard Deviation 15.11
|
2.0 microgram/liter (ug/L)
Standard Deviation 5.90
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 40
|
1.2 microgram/liter (ug/L)
Standard Deviation 6.48
|
1.2 microgram/liter (ug/L)
Standard Deviation 4.49
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 44
|
0.8 microgram/liter (ug/L)
Standard Deviation 5.10
|
1.2 microgram/liter (ug/L)
Standard Deviation 4.46
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 48
|
2.0 microgram/liter (ug/L)
Standard Deviation 9.20
|
0.6 microgram/liter (ug/L)
Standard Deviation 4.06
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 52
|
1.5 microgram/liter (ug/L)
Standard Deviation 5.82
|
0.7 microgram/liter (ug/L)
Standard Deviation 4.19
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 56
|
3.6 microgram/liter (ug/L)
Standard Deviation 18.56
|
0.9 microgram/liter (ug/L)
Standard Deviation 5.89
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 80
|
2.9 microgram/liter (ug/L)
Standard Deviation 10.15
|
0.7 microgram/liter (ug/L)
Standard Deviation 2.83
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 84
|
8.0 microgram/liter (ug/L)
Standard Deviation 33.13
|
0.1 microgram/liter (ug/L)
Standard Deviation 3.47
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 88
|
2.2 microgram/liter (ug/L)
Standard Deviation 3.89
|
0.6 microgram/liter (ug/L)
Standard Deviation 2.47
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 92
|
4.0 microgram/liter (ug/L)
Standard Deviation 7.24
|
0.1 microgram/liter (ug/L)
Standard Deviation 3.79
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 96
|
4.3 microgram/liter (ug/L)
Standard Deviation 5.96
|
0.0 microgram/liter (ug/L)
Standard Deviation 2.99
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 100
|
1.8 microgram/liter (ug/L)
Standard Deviation 3.79
|
-0.2 microgram/liter (ug/L)
Standard Deviation 5.10
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 108
|
5.5 microgram/liter (ug/L)
Standard Deviation 13.48
|
-0.5 microgram/liter (ug/L)
Standard Deviation 4.33
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 112
|
2.8 microgram/liter (ug/L)
Standard Deviation 5.72
|
-3.2 microgram/liter (ug/L)
Standard Deviation 3.30
|
—
|
—
|
|
Change From Baseline in Neuron Specific Enolase (NSE) Levels
Week 116
|
10.6 microgram/liter (ug/L)
Standard Deviation 14.92
|
0.2 microgram/liter (ug/L)
Standard Deviation 4.17
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to definitive deterioration of WHO performance status, assessed up to approximately 3 yearsPopulation: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
WHO PS is a scale rated from 0 (fully active) to 5 (death) by a healthcare professional to assess the overall status of a patient: a lower score represents a higher ability to perform daily tasks. Deterioration is defined as an increase of at least one point compared to baseline. Deterioration is considered definitive if no improvements in the WHO PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed. Death was considered as worsening of the WHO PS if it occurred close to the last available assessment, where "close" was defined as twice the planned period between two assessments. Patients without definitive worsening prior to analysis cut-off or prior to start of another anticancer therapy were censored at the date of their last assessment.
Outcome measures
| Measure |
Everolimus + BSC
n=205 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
n=97 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
Time to Definitive Deterioration in World Health Organization (WHO) Performance Status (PS) Change
|
24.08 Months
Interval 17.05 to
NA. Not evaluable due to the low number of participants with an event of interest.
|
24.15 Months
Interval 8.31 to
NA. Not evaluable due to the low number of participants with an event of interest.
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose at Day 29.Population: All patients who received at least one dose of the study drug with evaluable blood samples for this endpoint.
A pre-dose blood sample at day 29 was collected to determine the exposure of everolimus at the steady-state pre-dose concentration (Cmin). Cmin is provided for participants randomized to everolimus+BSC who received 10mg of everolimus daily and also for participants randomized to everolimus+BSC who received 5mg of everolimus daily which was required for a number of participants in the study experiencing adverse events requiring dose modifications
Outcome measures
| Measure |
Everolimus + BSC
n=48 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Predose Concentration (Cmin) of Everolimus at Day 29
10mg daily dose
|
16.382 nanogram/milliliter (ng/mL)
Standard Deviation 13.2767
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Predose Concentration (Cmin) of Everolimus at Day 29
5mg daily dose
|
4.700 nanogram/milliliter (ng/mL)
Standard Deviation 3.8396
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: On-treatment deaths: up to approximately 8 years. All deaths: up to approximately 8 yearsPopulation: The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
Deaths on-treatment were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approximately 8 years. Total Deaths were collected from first dose of study treatment until end of post-treatment survival follow, up to maximum duration of approximately 8 years.
Outcome measures
| Measure |
Everolimus + BSC
n=202 Participants
Participants received everolimus 10 mg once daily BSC throughout the study
|
Placebo + BSC
n=6 Participants
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
|
Everolimus+BSC (All)
n=208 Participants
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo + BSC (Blinded Period)
n=98 Participants
Participants received matching placebo once daily plus BSC during the blinded period
|
|---|---|---|---|---|
|
All Collected Deaths
On-treatment deaths
|
10 Participants
|
0 Participants
|
10 Participants
|
5 Participants
|
|
All Collected Deaths
Total deaths
|
126 Participants
|
1 Participants
|
127 Participants
|
57 Participants
|
Adverse Events
Everolimus+BSC (Throughout Study)
Serious events: 93 serious events
Other events: 197 other events
Deaths: 10 deaths
Everolimus +BSC (Crossover)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Everolimus+BSC (All)
Serious events: 94 serious events
Other events: 203 other events
Deaths: 10 deaths
Placebo+BSC (Blinded Period)
Serious events: 21 serious events
Other events: 81 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Everolimus+BSC (Throughout Study)
n=202 participants at risk
Participants received everolimus 10 mg once daily plus BSC throughout the study
|
Everolimus +BSC (Crossover)
n=6 participants at risk
Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC
|
Everolimus+BSC (All)
n=208 participants at risk
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo+BSC (Blinded Period)
n=98 participants at risk
Participants received matching placebo once daily plus best supportive care (BSC) during the blinded period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
7/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.4%
7/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Acute coronary syndrome
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Atrial fibrillation
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Atrial flutter
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Cardiac failure
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Cardiac failure chronic
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Cardiovascular disorder
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Myocardial infarction
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Myocardial ischaemia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Pericardial effusion
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Cardiac disorders
Tachycardia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Endocrine disorders
Adrenal insufficiency
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
13/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
6.7%
14/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
4.1%
4/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Ascites
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Colitis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Constipation
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
10/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
4.8%
10/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Enterocolitis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Ileus
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.0%
6/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.4%
7/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Subileus
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
5/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.4%
5/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Asthenia
|
3.0%
6/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.9%
6/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Chest discomfort
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Chills
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Fatigue
|
3.5%
7/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.4%
7/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
General physical health deterioration
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Mucosal inflammation
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Oedema peripheral
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Organ failure
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Performance status decreased
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Pyrexia
|
5.4%
11/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.3%
11/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Hepatobiliary disorders
Bile duct stone
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Hepatobiliary disorders
Cholangitis
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Hepatobiliary disorders
Hepatic failure
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Hepatobiliary disorders
Hepatic pain
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Immune system disorders
Contrast media allergy
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Cellulitis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Clostridium difficile infection
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Device related infection
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Incision site cellulitis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Infection
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Lower respiratory tract infection
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Peritonitis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Pneumonia
|
3.5%
7/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.4%
7/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Pneumonia bacterial
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Respiratory tract infection
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Salmonellosis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Sepsis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Septic shock
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Skin infection
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Upper respiratory tract infection
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Urinary tract infection
|
2.0%
4/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.9%
4/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Urosepsis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Viral myocarditis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Injury, poisoning and procedural complications
Fall
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Ejection fraction decreased
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Gastrointestinal stoma output decreased
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Troponin increased
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Weight decreased
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.9%
4/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Amnesia
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Cerebral infarction
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Disturbance in attention
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Dysarthria
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Epilepsy
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Headache
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Seizure
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Somnolence
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Syncope
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Psychiatric disorders
Delirium
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Psychiatric disorders
Stress
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
4/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.9%
4/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.1%
3/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Renal and urinary disorders
Hydronephrosis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Renal and urinary disorders
Renal failure
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Renal and urinary disorders
Renal impairment
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
5/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.4%
5/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
4/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.9%
4/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Vascular disorders
Hypertension
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Vascular disorders
Hypotension
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
Other adverse events
| Measure |
Everolimus+BSC (Throughout Study)
n=202 participants at risk
Participants received everolimus 10 mg once daily plus BSC throughout the study
|
Everolimus +BSC (Crossover)
n=6 participants at risk
Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC
|
Everolimus+BSC (All)
n=208 participants at risk
All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
|
Placebo+BSC (Blinded Period)
n=98 participants at risk
Participants received matching placebo once daily plus best supportive care (BSC) during the blinded period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.3%
47/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
22.6%
47/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
9.2%
9/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Ear and labyrinth disorders
Deafness
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.4%
5/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Endocrine disorders
Carcinoid syndrome
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Eye disorders
Blindness
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Eye disorders
Dry eye
|
2.0%
4/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.4%
5/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Eye disorders
Eye pain
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Eye disorders
Visual impairment
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
8.2%
8/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
38/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
18.8%
39/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
17.3%
17/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.4%
21/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
10.1%
21/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
11.2%
11/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.0%
8/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
50.0%
3/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.3%
11/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Constipation
|
12.4%
25/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
13.0%
27/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
19.4%
19/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Diarrhoea
|
43.6%
88/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
50.0%
3/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
43.8%
91/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
30.6%
30/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Dry mouth
|
8.9%
18/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
8.7%
18/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.1%
5/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
11/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.8%
12/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.1%
5/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Flatulence
|
3.5%
7/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.8%
8/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
6.1%
6/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.9%
18/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
8.7%
18/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Nausea
|
28.7%
58/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
27.9%
58/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.3%
16/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Stomatitis
|
55.9%
113/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
55.3%
115/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
19.4%
19/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Toothache
|
5.4%
11/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
6.2%
13/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.1%
3/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Gastrointestinal disorders
Vomiting
|
16.3%
33/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
15.9%
33/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
10.2%
10/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Asthenia
|
22.8%
46/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
22.1%
46/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
9.2%
9/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Chills
|
3.0%
6/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.4%
7/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Fatigue
|
37.6%
76/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
37.5%
78/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
36.7%
36/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Oedema peripheral
|
40.1%
81/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
39.4%
82/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.1%
5/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Peripheral swelling
|
5.4%
11/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.3%
11/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
General disorders
Pyrexia
|
24.3%
49/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
24.5%
51/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
9.2%
9/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Immune system disorders
Hypersensitivity
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Bronchitis
|
4.0%
8/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
4.8%
10/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Cystitis
|
3.5%
7/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.8%
8/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Influenza
|
4.5%
9/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.3%
11/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
22/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
11.5%
24/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
4.1%
4/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Pneumonia
|
8.9%
18/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
8.7%
18/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Rhinitis
|
2.0%
4/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.4%
5/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
18/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
9.1%
19/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
6.1%
6/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Infections and infestations
Urinary tract infection
|
11.4%
23/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
11.5%
24/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
6.1%
6/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.9%
4/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
12/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.8%
12/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Blood alkaline phosphatase increased
|
1.5%
3/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.1%
5/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Blood creatinine increased
|
5.4%
11/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.8%
12/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Blood urea
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Blood uric acid
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.5%
9/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
4.8%
10/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Investigations
Weight decreased
|
25.2%
51/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
25.5%
53/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
11.2%
11/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.2%
53/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
26.0%
54/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
17.3%
17/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.9%
16/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
8.2%
17/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.9%
24/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
12.0%
25/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
6.1%
6/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.9%
12/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
6.2%
13/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.4%
21/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
50.0%
3/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
11.5%
24/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
4.1%
4/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.5%
5/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.9%
6/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.3%
31/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
14.9%
31/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
8.2%
8/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.8%
34/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.3%
34/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
14.3%
14/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.5%
5/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.9%
6/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.1%
3/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
15/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
7.2%
15/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
4.1%
4/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.9%
4/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.4%
19/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
9.1%
19/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.1%
5/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Dizziness
|
5.4%
11/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.3%
11/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.1%
5/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Dysgeusia
|
12.9%
26/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
13.0%
27/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.1%
3/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Headache
|
13.4%
27/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
13.5%
28/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
15.3%
15/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Paraesthesia
|
2.5%
5/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.4%
7/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Syncope
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Nervous system disorders
Taste disorder
|
6.4%
13/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
6.7%
14/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Psychiatric disorders
Anxiety
|
4.5%
9/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
4.8%
10/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Psychiatric disorders
Insomnia
|
9.9%
20/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
9.6%
20/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
8.2%
8/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Renal and urinary disorders
Dysuria
|
4.0%
8/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.8%
8/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.1%
5/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Renal and urinary disorders
Haematuria
|
5.4%
11/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.8%
12/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
4.1%
4/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Renal and urinary disorders
Proteinuria
|
8.9%
18/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
8.7%
18/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.2%
63/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
30.8%
64/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
20.4%
20/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.0%
6/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.4%
7/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.0%
1/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.8%
42/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
20.2%
42/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
11.2%
11/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.9%
28/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
14.4%
30/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.1%
3/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.48%
1/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.4%
13/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
6.7%
14/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.1%
3/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
12/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.8%
12/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.9%
30/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
14.4%
30/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.99%
2/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
1.4%
3/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
9.9%
20/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
9.6%
20/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.1%
3/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.9%
18/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
8.7%
18/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.0%
6/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
3.4%
7/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.4%
11/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
5.3%
11/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
2.0%
2/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.50%
1/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.96%
2/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
0.00%
0/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.3%
37/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
33.3%
2/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
18.8%
39/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
9.2%
9/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.7%
62/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
50.0%
3/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
31.2%
65/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
9.2%
9/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
|
Vascular disorders
Hypertension
|
13.9%
28/202 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
16.7%
1/6 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
13.9%
29/208 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
10.2%
10/98 • Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
|
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 the clinical trial
- Publication restrictions are in place
Restriction type: OTHER