Trial Outcomes & Findings for Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy (NCT NCT00419159)
NCT ID: NCT00419159
Last Updated: 2019-04-23
Results Overview
RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
199 participants
Primary outcome timeframe
Imaging every 8 weeks
Results posted on
2019-04-23
Participant Flow
Participant milestones
| Measure |
Everolimus (RAD001) 70 mg/Week
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
100
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
99
|
100
|
Reasons for withdrawal
| Measure |
Everolimus (RAD001) 70 mg/Week
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
15
|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
2
|
|
Overall Study
Subject's no longer requires study drug
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Disease progression
|
79
|
76
|
Baseline Characteristics
Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy
Baseline characteristics by cohort
| Measure |
Everolimus (RAD001) 70 mg/Week
n=99 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=100 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Age, Customized
<45 Years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Customized
45 to <55 Years
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Customized
55 to <65 Years
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Customized
> or = to 65 Years
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Imaging every 8 weeksPopulation: Per Protocol Set
RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response).
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=71 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=71 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Disease Control Rate (DCR)
|
31.0 Percentage of participants
Interval 20.5 to 43.1
|
32.4 Percentage of participants
Interval 21.8 to 44.5
|
|
Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Objective Response Rate (ORR)
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Imaging every 8 weeksPopulation: Full Analysis Set
RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Best Over Response (BOR): Complete Response (CR, No lesions), Partial Response (PR, 30% decrease in lesions), and Stable Disease (SD, none of the above)
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=99 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=100 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response (CR)
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response (PR)
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease (SD)
|
25 Participants
|
26 Participants
|
|
The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease (PD)
|
58 Participants
|
55 Participants
|
|
The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Disease Control (CR or PR or SD)
|
25 Participants
|
26 Participants
|
|
The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Objective Response (CR or PR)
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Unknown
|
16 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Imaging every 8 weeksPopulation: Progression- Free Survival (PFS) was analyzed in Full Analysis Set \[FAS\].
Duration in months from the date of first study treatment to the date of the first documented disease progression or death due to any cause.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=99 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=100 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
1.77 Months
Interval 1.68 to 1.84
|
1.77 Months
Interval 1.68 to 1.87
|
SECONDARY outcome
Timeframe: Every 3 monthsPopulation: Overall Survival \[OS\] was analyzed in Full Analysis Set \[FAS\].
Overall survival defined as the time from date of first study treatment to the date of death due to any cause.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=99 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=100 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Overall Survival (OS)
|
4.90 Months
Interval 4.04 to 6.6
|
5.88 Months
Interval 4.7 to 7.06
|
SECONDARY outcome
Timeframe: From the first day of treatment until 28 days after discontinuation of study treatmentPopulation: Safety set analysis
Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAEv3.0). On treatment death defined as deaths occurring no more than 28 days after the discontinuation of study treatment.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=99 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=100 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).
AE leading to discontinuation
|
9 Participants
|
20 Participants
|
|
Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).
Deaths
|
86 Participants
|
65 Participants
|
|
Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).
On-treatment Death
|
11 Participants
|
14 Participants
|
|
Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).
SAE regardless of relationship to study treatment
|
34 Participants
|
22 Participants
|
|
Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).
SAE with suspected relationship to study treatment
|
7 Participants
|
6 Participants
|
|
Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).
AE Grade 3-4, regardless of relationship to study
|
58 Participants
|
50 Participants
|
|
Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).
AE Grade 3-4, suspected relationship to study tr
|
31 Participants
|
26 Participants
|
|
Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).
Clinically notable adverse event
|
85 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: Screening and Day 1 of cycles 2, 3, 4 and end of treatmentPopulation: FAS
The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=33 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=44 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 70 mg/Week
|
33.3 percentage of participants
Interval 18.0 to 51.8
|
21.7 percentage of participants
Interval 10.9 to 36.4
|
SECONDARY outcome
Timeframe: Screening and Day 1 of cycles 2, 3, 4 and end of treatmentPopulation: FAS
The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=41 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=40 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 10 mg/Day
|
17.1 percentage of participants
Interval 7.2 to 32.1
|
35.0 percentage of participants
Interval 20.6 to 51.7
|
SECONDARY outcome
Timeframe: Screening and Day 1 of cycles 2, 3, 4 and end of treatmentPopulation: FAS
The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=33 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=46 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS ) on Everolimus (RAD001) 70mg/Week
Median PFS
|
1.77 months
Interval 1.64 to 2.37
|
1.71 months
Interval 1.64 to 1.81
|
|
Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS ) on Everolimus (RAD001) 70mg/Week
Median OS
|
6.18 months
Interval 2.4 to 8.05
|
4.90 months
Interval 3.65 to 6.6
|
SECONDARY outcome
Timeframe: Screening and Day 1 of cycles 2, 3, 4 and end of treatmentPopulation: FAS
The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=41 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=40 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS) on Everolimus (RAD001) 10mg/Day
Median PFS
|
1.71 months
Interval 1.68 to 1.84
|
1.77 months
Interval 1.64 to 3.22
|
|
Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS) on Everolimus (RAD001) 10mg/Day
Median OS
|
5.59 months
Interval 4.24 to 7.69
|
7.06 months
Interval 5.32 to
N/A: upper limit of CI could not be reached as there were not enough patients
|
SECONDARY outcome
Timeframe: Screening and Day 1 of cycles 2, 3, 4 and end of treatmentPopulation: FAS
The efficacy variable that was compared in the biomarker analysis is DCR within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=43 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=30 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 70mg/Week
|
20.9 percentage of participants
Interval 10.0 to 36.0
|
33.3 percentage of participants
Interval 17.3 to 52.8
|
SECONDARY outcome
Timeframe: Screening and Day 1 of cycles 2, 3, 4 and end of treatmentPopulation: FAS
The efficacy variable that was compared in the biomarker analysis is DCR within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=26 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=46 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 10mg/Day
|
26.9 percentage of participants
Interval 11.6 to 47.8
|
26.1 percentage of participants
Interval 14.3 to 41.1
|
SECONDARY outcome
Timeframe: Screening and Day 1 of cycles 2, 3, 4 and end of treatmentPopulation: FAS
The efficacy variable that was compared in the biomarker analysis are PFS \& OS within the Everolimus (RAD001) 70mg/Week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=43 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=30 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 70mg/Week
Median PFS
|
1.71 months
Interval 1.64 to 1.81
|
1.77 months
Interval 1.64 to 3.48
|
|
Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 70mg/Week
Median OS
|
5.98 months
Interval 3.48 to 7.92
|
4.37 months
Interval 2.43 to 7.26
|
SECONDARY outcome
Timeframe: Screening and Day 1 of cycles 2, 3, 4 and end of treatmentPopulation: FAS
The efficacy variable that was compared in the biomarker analysis are PFS \& OS within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.
Outcome measures
| Measure |
Everolimus (RAD001) 70 mg/Week
n=26 Participants
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=46 Participants
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 10mg/Day
Median PFS
|
1.81 months
Interval 1.68 to 2.14
|
1.68 months
Interval 1.64 to 1.94
|
|
Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 10mg/Day
Median OS
|
10.38 months
Interval 5.52 to 14.69
|
6.34 months
Interval 4.63 to 9.63
|
Adverse Events
Everolimus (RAD001) 70 mg/Week
Serious events: 34 serious events
Other events: 99 other events
Deaths: 0 deaths
Everolimus (RAD001) 10 mg/Day
Serious events: 22 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Everolimus (RAD001) 70 mg/Week
n=99 participants at risk
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=100 participants at risk
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
2.0%
2/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
3/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
3.0%
3/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
4/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
3/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
3.0%
3/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Asthenia
|
3.0%
3/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Chest pain
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Multi-organ failure
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
2.0%
2/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Pain
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Pyrexia
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Hepatobiliary disorders
Jaundice
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Infections and infestations
Catheter related infection
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Infections and infestations
Central line infection
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Infections and infestations
Pneumonia
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Blood creatinine increased
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
International normalised ratio increased
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Lipase increased
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
4/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Nervous system disorders
Central nervous system lesion
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Psychiatric disorders
Confusional state
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
2.0%
2/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
3/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
2.0%
2/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
0.00%
0/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
Other adverse events
| Measure |
Everolimus (RAD001) 70 mg/Week
n=99 participants at risk
Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
Everolimus (RAD001) 10 mg/Day
n=100 participants at risk
Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.3%
25/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
19.0%
19/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
9/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
4.0%
4/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.2%
16/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
18.0%
18/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
7/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
18/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
13.0%
13/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
6/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
6.1%
6/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
2.0%
2/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
20.2%
20/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
13.0%
13/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
27/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
26.0%
26/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
3.0%
3/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
7.0%
7/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
6/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
3.0%
3/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.4%
40/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
22.0%
22/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
17.2%
17/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
22.0%
22/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.3%
25/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
13.0%
13/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Asthenia
|
14.1%
14/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
23.0%
23/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Chills
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Fatigue
|
50.5%
50/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
37.0%
37/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Mucosal inflammation
|
17.2%
17/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
11.0%
11/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Oedema peripheral
|
16.2%
16/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
14.0%
14/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
General disorders
Pyrexia
|
12.1%
12/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
15.0%
15/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
4/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
6.0%
6/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
8/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
2.0%
2/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
8.1%
8/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.1%
8/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
6.0%
6/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.1%
8/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
13.0%
13/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Investigations
Weight decreased
|
14.1%
14/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
14.0%
14/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.3%
30/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
25.0%
25/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.1%
10/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
11.0%
11/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
13.1%
13/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
10.0%
10/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.1%
13/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
9.0%
9/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.1%
6/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
3.0%
3/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.1%
6/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
3.0%
3/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
4.0%
4/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.1%
10/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
8.0%
8/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
3.0%
3/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
8.0%
8/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
6/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
6.0%
6/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Nervous system disorders
Headache
|
10.1%
10/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
7.0%
7/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Psychiatric disorders
Anxiety
|
2.0%
2/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Psychiatric disorders
Insomnia
|
9.1%
9/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
6.0%
6/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
1.0%
1/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.1%
13/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
16.0%
16/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
18/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
19.0%
19/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
10.0%
10/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.1%
6/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
2.0%
2/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
7.0%
7/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.1%
5/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
3.0%
3/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
8/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
34.3%
34/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
29.0%
29/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
|
Vascular disorders
Hypertension
|
3.0%
3/99 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
5.0%
5/100 • Adverse events occurring up to 28 days after the discontinuation of study treatment.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER