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Trial record 5 of 8 for:    "Angiomyolipoma" | "Immunosuppressive Agents"

Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) (EXIST-2)

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ClinicalTrials.gov Identifier: NCT00790400
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : August 28, 2012
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Tuberous Sclerosis Complex (TSC)
Lymphangioleiomyomatosis (LAM)
Interventions Drug: Everolimus (RAD001)
Drug: Everolimus Placebo
Enrollment 118
Recruitment Details A multicenter trial conducted at 24 sites in 11 countries. As the primary analysis of the core phase of the study favored everolimus over placebo, an open-label extension phase started: patients randomized in placebo were offered to switch on everolimus and those still receiving everolimus at the end of the core phase could continue the treatment.
Pre-assignment Details The trial had a 2:1 randomization in favor of the everolimus arm. 118 patients were randomized to the core phase of the study. 112 patients received everolimus during core and/or extension phase.
Arm/Group Title Everolimus Placebo
Hide Arm/Group Description Study drug was given by continuous oral daily dosing of two 5 mg tablets. Placebo was given by continuous oral daily dosing of two 5 mg tablets.
Period Title: Double-blind Period (Core Phase)
Started 79 39
Completed 72 [1] 26 [2]
Not Completed 7 13
Reason Not Completed
Protocol Violation             1             0
Progressive disease             0             9
Adverse Event             2             4
Abnormal lab value (s)             1             0
Withdrawal by Subject             1             0
Administrative problems             1             0
Death             1             0
[1]
Completed = Completed the Core phase & moved to Extension phase
[2]
Completed = 1st received Placebo in the Core phase, switched to Everolimus in Extension phase
Period Title: Everolimus Period (Core or Extension)
Started 112 [1] 0 [2]
Completed 83 [3] 0
Not Completed 29 0
Reason Not Completed
Adverse Event             9             0
Abnormal lab value (s)             1             0
Withdrawal by Subject             7             0
Lost to Follow-up             1             0
Administrative problems             2             0
Death             1             0
Disease progression             5             0
Protocol Violation             1             0
New treatment             2             0
[1]
112 pts had Everolimus during core and/or extension (6 from placebo did not switch to Eve. in ext.)
[2]
Placebo randomized patients who switched to Everolimus are reported in "Everolimus" arm.
[3]
Treatment duration completed as per protocol
Arm/Group Title Everolimus Placebo Total
Hide Arm/Group Description Study drug was given by continuous oral daily dosing of two 5 mg tablets. Placebo was given by continuous oral daily dosing of two 5 mg tablets. Total of all reporting groups
Overall Number of Baseline Participants 79 39 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 39 participants 118 participants
32.5  (10.37) 31.0  (9.64) 32.0  (10.12)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 39 participants 118 participants
<30 years 35 20 55
≥ 30 years 44 19 63
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 39 participants 118 participants
Female
52
  65.8%
26
  66.7%
78
  66.1%
Male
27
  34.2%
13
  33.3%
40
  33.9%
1.Primary Outcome
Title Angiomyolipoma Response Rate as Per Central Radiology Review
Hide Description

Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.

For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.

Time Frame From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.
Arm/Group Title Everolimus Randomized (Core Period) Placebo Randomized (Core Period) Everolimus (Core and/or Extension Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Placebo was given by continuous oral daily dosing of two 5 mg tablets.
Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
Overall Number of Participants Analyzed 79 39 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
41.8
(30.8 to 53.4)
0
(0.0 to 9.0)
58.0
(48.3 to 67.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Everolimus Randomized (Core Period), Placebo Randomized (Core Period)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Clopper-Pearson
Comments [Not Specified]
2.Secondary Outcome
Title Time to Angiomyolipoma Progression as Per Central Radiology Review
Hide Description

Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2.

For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. The baseline means the latest value on or before starting everolimus.

Time Frame From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.
Arm/Group Title Everolimus Randomized (Core Period) Placebo Randomized (Core Period) Everolimus (Core and/or Extension Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Placebo was given by continuous oral daily dosing of two 5 mg tablets.
Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
Overall Number of Participants Analyzed 79 39 112
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
11.37 [2] 
(11.07 to NA)
NA [3] 
(NA to NA)
[1]
Median not reached since too few number of patients with progressions (n=3).
[2]
Upper limit not estimable due to few number of patients at this time point.
[3]
Median not reached since too few number of patients with progressions (n=16)
3.Secondary Outcome
Title Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)
Hide Description Skin lesion response rate in the double-blind period was determined only among patients with at least one skin lesion at baseline, and is the percentage of this group of patients with a best overall skin lesion response on the Physician’s Global Assessment of Clinical Condition (PGA) of either complete clinical response (CCR) or partial response (PR). A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement. For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.
Time Frame From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. Only patients with at least one skin lesion at baseline are included in the analysis.
Arm/Group Title Everolimus Randomized (Core Period) Placebo Randomized (Core Period) Everolimus (Core and/or Extension Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Placebo was given by continuous oral daily dosing of two 5 mg tablets.
Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
Overall Number of Participants Analyzed 77 37 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
26
(16.6 to 37.2)
0
(0.0 to 9.5)
68.2
(58.5 to 76.9)
4.Secondary Outcome
Title Percentage of Participants With Renal Impairment
Hide Description Renal Impairment was measured by glomerular filtration rate which was calculated using the Modification of Diet in Renal Disease formula. Percentage of participants with renal impairment was reported. Severe renal impairment was defined as a GFR of <30ml/min/1.73m2.
Time Frame Day 1 up to 28 days after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set consists of all patients who received at least 1 dose of the double-blind study drug with a valid post-baseline assessment. For the everolimus (core/extension) treatment arm, patients received at least 1 dose of everolimus with a valid post-baseline assessment, where baseline was defined as the assessment just before start of everolimus.
Arm/Group Title Everolimus Randomized (Core Period) Placebo Randomized (Core Period) Everolimus (Core and/or Extension Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Placebo was given by continuous oral daily dosing of two 5 mg tablets.
Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
Overall Number of Participants Analyzed 79 39 112
Measure Type: Number
Unit of Measure: Percentage of Participants
Glomerular filtration rate <30 ml/min/1.73m^2 2.5 7.7 7.1
Glomerular filtration rate≥ 30 ml/min/1.73m^2 97.5 92.3 92.9
5.Secondary Outcome
Title Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor (VEGF) Marker
Hide Description Blood samples for biomarker assessment were collected immediately prior to study administration. On-treatment samples was compared to baseline samples with the change from baseline.
Time Frame 4 weeks, 12 weeks, 24 weeks, 36 weeks 48 weeks, 60 weeks, 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Everolimus Randomized (Core Period) Placebo Randomized (Core Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Placebo was given by continuous oral daily dosing of two 5 mg tablets.
Overall Number of Participants Analyzed 79 39
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n:56, 28) 38.7  (141.89) 17.6  (57.51)
Week 12 (n:56, 29) 43.4  (60.62) -6.1  (46.28)
Week 24 (n:53, 29) 31.1  (75.83) -4.3  (44.76)
Week 36 (n:26, 18) 18.0  (45.07) 5.4  (24.01)
Week 48 (n:16, 8) 55.3  (80.31) 3.1  (34.55)
Week 60 (n:0, 1) NA [1]   (NA) -4.12 [2]   (NA)
Week 72 (n:0, 1) NA [3]   (NA) -6.1 [2]   (NA)
[1]
N/A = No patient was included at this time point, so no mean, no standard deviation (SD) could be calculated.
[2]
N/A = only 1 patient was included, so no SD could be calculated
[3]
N/A = No patient was included at this time point, so no mean, no SD could be calculated.
6.Secondary Outcome
Title Everolimus Trough Concentrations (Cmin)
Hide Description Cmin values collected prior to dose administration on the same study day and at 20-28 hours after previous dose, at steady state, and patient did not vomit within 4 hours of previous dose. Samples collected during the first 4 days of dosing were excluded from all analyses.
Time Frame Prior to dosing at weeks 2, 4, 12, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.
Arm/Group Title Everolimus Randomized (Core Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: ng/mL
Prior to dosing at Week 2 (n:43) 7.63  (4.32)
Prior to dosing Week 4 (n:44) 7.72  (4.35)
Prior to dosing Week 12 (n:49) 8.79  (6.75)
Prior to dosing Week 24 (n:46) 9.37  (8.83)
Prior to dosing Week 48 (n:15) 11.49  (12.01)
7.Secondary Outcome
Title Everolimus Blood Concentrations (C2h) at 2 Hours Post-dose
Hide Description C2h values collected 1-3 hours after dose administration on the same study day, at steady state, and patient did not vomit between taking previous dose and blood collection. Samples collected during the first 4 days of dosing will be excluded from all analyses.
Time Frame 2 hours post-dose administration at Weeks 2, 4, 12, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.
Arm/Group Title Everolimus Randomized (Core Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: ng/mL
2 hours post dose administration at Week 2 (n:55) 33.38  (15.66)
2 hours post dose administration at Week 4 (n:49) 30.89  (14.96)
2 hours post dose administration at Week 12 (n:56) 34.48  (15.10)
2 hours post dose administration at Week 24 (n:50) 39.27  (22.25)
2 hours post dose administration at Week 48 (n:14) 33.20  (18.45)
8.Secondary Outcome
Title Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response
Hide Description

Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; no kidney increases in volume > 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2.

For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition means the latest value on or before starting everolimus.

Time Frame From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.
Arm/Group Title Everolimus Randomized (Core Period) Everolimus (Core and/or Extension Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
Overall Number of Participants Analyzed 33 65
Median (95% Confidence Interval)
Unit of Measure: months
2.86
(2.79 to 3.02)
2.89
(2.79 to 3.19)
9.Secondary Outcome
Title Duration of Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response
Hide Description Duration of angiomyolipoma response was defined as the time from the date of the first documented angiomyolipoma response until the date of the first documented angiomyolipoma progression . Angiomyolipoma response was defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.
Time Frame From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.
Arm/Group Title Everolimus Randomized (Core Period) Everolimus (Core and/or Extension Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
Overall Number of Participants Analyzed 33 65
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
N/A = Median not reached since no patients progressed
[2]
N/A = Median not reached since too few no of patients with progressions (n=2)
10.Secondary Outcome
Title Duration of Skin Lesion Response - Only Everolimus Patients With Best Overall Skin Lesion Response of Complete Clinical Response (CCR) or Partial Response (PR)
Hide Description Duration of skin lesion response is defined as the time from the date of the first skin lesion response until the date of the first skin lesion progression, according to the PGA (physician’s global assessment of clinical condition). A progression is when the disease is worse than at baseline evaluation by >=25% or more.
Time Frame From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced a best overall skin lesion response CCR or PR.
Arm/Group Title Everolimus Randomized (Core Period) Everolimus (Core and/or Extension Period)
Hide Arm/Group Description:
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
Overall Number of Participants Analyzed 20 73
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
N/A = Median not reached since no patients progressed
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Everolimus Randomized (Core & Ext) Placebo Randomized/Crossed Over to Everolimus Placebo Randomized/Never Crossed-over
Hide Arm/Group Description Patients who were randomized and treated with Everolimus during the Core and Extension phase Patients who were randomized to placebo in the Core phase and who crossed-over to Everolimus in the Extension phase Patients randomized to placebo who never crossed-over to Everolimus
All-Cause Mortality
Everolimus Randomized (Core & Ext) Placebo Randomized/Crossed Over to Everolimus Placebo Randomized/Never Crossed-over
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Everolimus Randomized (Core & Ext) Placebo Randomized/Crossed Over to Everolimus Placebo Randomized/Never Crossed-over
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/79 (35.44%)   17/33 (51.52%)   3/6 (50.00%) 
Blood and lymphatic system disorders       
Bone marrow oedema  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Cardiac disorders       
Cardiac failure congestive  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Cardiovascular insufficiency  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Ear and labyrinth disorders       
Vertigo positional  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Eye disorders       
Visual acuity reduced  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders       
Abdominal adhesions  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Abdominal compartment syndrome  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Abdominal hernia  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Colitis  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Constipation  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Diarrhoea  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Diarrhoea haemorrhagic  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Gastric ulcer  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Ileal perforation  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Intestinal perforation  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Salivary gland calculus  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Volvulus  1  0/79 (0.00%)  0/33 (0.00%)  1/6 (16.67%) 
Vomiting  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
General disorders       
Adverse drug reaction  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Fatigue  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders       
Bile duct stenosis  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Immune system disorders       
Hypersensitivity  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Infections and infestations       
Abscess  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Appendicitis  1  2/79 (2.53%)  0/33 (0.00%)  0/6 (0.00%) 
Bronchitis  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Bronchopneumonia  1  1/79 (1.27%)  1/33 (3.03%)  0/6 (0.00%) 
Campylobacter gastroenteritis  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Erysipelas  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Gastroenteritis  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Gastrointestinal infection  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Incision site infection  1  0/79 (0.00%)  0/33 (0.00%)  1/6 (16.67%) 
Peritonitis  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Pneumonia  1  1/79 (1.27%)  3/33 (9.09%)  0/6 (0.00%) 
Pyelonephritis  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Sepsis  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Tonsillitis  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Urinary tract infection  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Viral infection  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Toxicity to various agents  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Investigations       
Blood creatinine increased  1  2/79 (2.53%)  0/33 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Gout  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Chondropathy  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Joint effusion  1  2/79 (2.53%)  0/33 (0.00%)  0/6 (0.00%) 
Rhabdomyolysis  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Spinal osteoarthritis  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Angiomyolipoma  1  0/79 (0.00%)  0/33 (0.00%)  1/6 (16.67%) 
Nasal sinus cancer  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Pancreatic carcinoma  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Nervous system disorders       
Complex regional pain syndrome  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Convulsion  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Diplegia  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Epilepsy  1  3/79 (3.80%)  3/33 (9.09%)  0/6 (0.00%) 
Generalised tonic-clonic seizure  1  2/79 (2.53%)  1/33 (3.03%)  0/6 (0.00%) 
Hydrocephalus  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Syncope  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Transient ischaemic attack  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Psychiatric disorders       
Affective disorder  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Aggression  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Alcohol abuse  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Anxiety  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Hallucination  1  1/79 (1.27%)  0/33 (0.00%)  1/6 (16.67%) 
Psychiatric decompensation  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Psychogenic seizure  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Psychotic disorder  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders       
Renal failure acute  1  1/79 (1.27%)  1/33 (3.03%)  0/6 (0.00%) 
Renal failure chronic  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Renal haemorrhage  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Renal impairment  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Reproductive system and breast disorders       
Breast hypoplasia  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Endometrial hyperplasia  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Ovarian cyst  1  1/79 (1.27%)  1/33 (3.03%)  0/6 (0.00%) 
Ovarian cyst ruptured  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchospasm  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Haemoptysis  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Pleuritic pain  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Pneumothorax  1  2/79 (2.53%)  1/33 (3.03%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders       
Angioedema  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Vascular disorders       
Aortic aneurysm  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Haemodynamic instability  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Hypertension  1  0/79 (0.00%)  1/33 (3.03%)  0/6 (0.00%) 
Hypertensive crisis  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Thrombosis  1  1/79 (1.27%)  0/33 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Everolimus Randomized (Core & Ext) Placebo Randomized/Crossed Over to Everolimus Placebo Randomized/Never Crossed-over
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   79/79 (100.00%)   33/33 (100.00%)   5/6 (83.33%) 
Blood and lymphatic system disorders       
Anaemia  1  9/79 (11.39%)  6/33 (18.18%)  0/6 (0.00%) 
Leukopenia  1  9/79 (11.39%)  7/33 (21.21%)  0/6 (0.00%) 
Lymphopenia  1  5/79 (6.33%)  5/33 (15.15%)  0/6 (0.00%) 
Neutropenia  1  7/79 (8.86%)  4/33 (12.12%)  0/6 (0.00%) 
Thrombocytopenia  1  6/79 (7.59%)  3/33 (9.09%)  0/6 (0.00%) 
Cardiac disorders       
Palpitations  1  0/79 (0.00%)  2/33 (6.06%)  0/6 (0.00%) 
Tachycardia  1  2/79 (2.53%)  2/33 (6.06%)  0/6 (0.00%) 
Congenital, familial and genetic disorders       
Hamartoma  1  1/79 (1.27%)  3/33 (9.09%)  0/6 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  3/79 (3.80%)  4/33 (12.12%)  0/6 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  13/79 (16.46%)  5/33 (15.15%)  2/6 (33.33%) 
Abdominal pain upper  1  7/79 (8.86%)  4/33 (12.12%)  1/6 (16.67%) 
Aphthous stomatitis  1  19/79 (24.05%)  12/33 (36.36%)  1/6 (16.67%) 
Constipation  1  8/79 (10.13%)  6/33 (18.18%)  1/6 (16.67%) 
Dental caries  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Diarrhoea  1  17/79 (21.52%)  11/33 (33.33%)  1/6 (16.67%) 
Dyspepsia  1  4/79 (5.06%)  0/33 (0.00%)  0/6 (0.00%) 
Flatulence  1  5/79 (6.33%)  3/33 (9.09%)  0/6 (0.00%) 
Gastrooesophageal reflux disease  1  4/79 (5.06%)  0/33 (0.00%)  0/6 (0.00%) 
Mouth ulceration  1  15/79 (18.99%)  4/33 (12.12%)  1/6 (16.67%) 
Nausea  1  18/79 (22.78%)  7/33 (21.21%)  2/6 (33.33%) 
Stomatitis  1  41/79 (51.90%)  10/33 (30.30%)  0/6 (0.00%) 
Toothache  1  5/79 (6.33%)  3/33 (9.09%)  0/6 (0.00%) 
Vomiting  1  18/79 (22.78%)  5/33 (15.15%)  0/6 (0.00%) 
General disorders       
Asthenia  1  2/79 (2.53%)  2/33 (6.06%)  0/6 (0.00%) 
Fatigue  1  17/79 (21.52%)  13/33 (39.39%)  1/6 (16.67%) 
Influenza like illness  1  2/79 (2.53%)  5/33 (15.15%)  1/6 (16.67%) 
Malaise  1  0/79 (0.00%)  2/33 (6.06%)  0/6 (0.00%) 
Oedema peripheral  1  16/79 (20.25%)  10/33 (30.30%)  0/6 (0.00%) 
Pyrexia  1  11/79 (13.92%)  6/33 (18.18%)  1/6 (16.67%) 
Immune system disorders       
Hypersensitivity  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Seasonal allergy  1  3/79 (3.80%)  2/33 (6.06%)  0/6 (0.00%) 
Infections and infestations       
Bronchitis  1  9/79 (11.39%)  9/33 (27.27%)  1/6 (16.67%) 
Cellulitis  1  2/79 (2.53%)  4/33 (12.12%)  0/6 (0.00%) 
Conjunctivitis  1  4/79 (5.06%)  2/33 (6.06%)  0/6 (0.00%) 
Ear infection  1  5/79 (6.33%)  1/33 (3.03%)  0/6 (0.00%) 
Folliculitis  1  4/79 (5.06%)  1/33 (3.03%)  0/6 (0.00%) 
Furuncle  1  4/79 (5.06%)  2/33 (6.06%)  0/6 (0.00%) 
Gastroenteritis  1  9/79 (11.39%)  4/33 (12.12%)  0/6 (0.00%) 
Gastroenteritis viral  1  4/79 (5.06%)  0/33 (0.00%)  0/6 (0.00%) 
Gastrointestinal infection  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Gingivitis  1  2/79 (2.53%)  3/33 (9.09%)  0/6 (0.00%) 
Influenza  1  8/79 (10.13%)  3/33 (9.09%)  1/6 (16.67%) 
Nasopharyngitis  1  36/79 (45.57%)  19/33 (57.58%)  1/6 (16.67%) 
Oral candidiasis  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Oral herpes  1  5/79 (6.33%)  1/33 (3.03%)  0/6 (0.00%) 
Otitis externa  1  0/79 (0.00%)  3/33 (9.09%)  0/6 (0.00%) 
Otitis media  1  6/79 (7.59%)  2/33 (6.06%)  0/6 (0.00%) 
Periodontitis  1  6/79 (7.59%)  0/33 (0.00%)  0/6 (0.00%) 
Pharyngitis  1  5/79 (6.33%)  1/33 (3.03%)  0/6 (0.00%) 
Pharyngitis streptococcal  1  5/79 (6.33%)  0/33 (0.00%)  0/6 (0.00%) 
Pneumonia  1  6/79 (7.59%)  2/33 (6.06%)  0/6 (0.00%) 
Rash pustular  1  7/79 (8.86%)  3/33 (9.09%)  0/6 (0.00%) 
Respiratory tract infection  1  5/79 (6.33%)  2/33 (6.06%)  0/6 (0.00%) 
Respiratory tract infection viral  1  5/79 (6.33%)  0/33 (0.00%)  0/6 (0.00%) 
Rhinitis  1  7/79 (8.86%)  6/33 (18.18%)  1/6 (16.67%) 
Sinusitis  1  11/79 (13.92%)  4/33 (12.12%)  1/6 (16.67%) 
Tonsillitis  1  1/79 (1.27%)  6/33 (18.18%)  0/6 (0.00%) 
Tooth abscess  1  7/79 (8.86%)  2/33 (6.06%)  0/6 (0.00%) 
Tooth infection  1  4/79 (5.06%)  3/33 (9.09%)  0/6 (0.00%) 
Upper respiratory tract infection  1  15/79 (18.99%)  4/33 (12.12%)  0/6 (0.00%) 
Urinary tract infection  1  25/79 (31.65%)  12/33 (36.36%)  1/6 (16.67%) 
Injury, poisoning and procedural complications       
Contusion  1  0/79 (0.00%)  3/33 (9.09%)  0/6 (0.00%) 
Fall  1  2/79 (2.53%)  2/33 (6.06%)  0/6 (0.00%) 
Incision site pain  1  0/79 (0.00%)  0/33 (0.00%)  1/6 (16.67%) 
Laceration  1  3/79 (3.80%)  2/33 (6.06%)  0/6 (0.00%) 
Procedural pain  1  2/79 (2.53%)  2/33 (6.06%)  1/6 (16.67%) 
Investigations       
Activated partial thromboplastin time prolonged  1  10/79 (12.66%)  5/33 (15.15%)  0/6 (0.00%) 
Alanine aminotransferase increased  1  9/79 (11.39%)  5/33 (15.15%)  0/6 (0.00%) 
Aspartate aminotransferase increased  1  10/79 (12.66%)  2/33 (6.06%)  0/6 (0.00%) 
Blood alkaline phosphatase increased  1  11/79 (13.92%)  5/33 (15.15%)  0/6 (0.00%) 
Blood cholesterol increased  1  11/79 (13.92%)  3/33 (9.09%)  0/6 (0.00%) 
Blood creatine phosphokinase increased  1  3/79 (3.80%)  5/33 (15.15%)  0/6 (0.00%) 
Blood creatinine increased  1  4/79 (5.06%)  4/33 (12.12%)  0/6 (0.00%) 
Blood fibrinogen increased  1  4/79 (5.06%)  5/33 (15.15%)  0/6 (0.00%) 
Blood lactate dehydrogenase increased  1  9/79 (11.39%)  4/33 (12.12%)  0/6 (0.00%) 
Blood phosphorus decreased  1  6/79 (7.59%)  1/33 (3.03%)  0/6 (0.00%) 
Blood triglycerides increased  1  10/79 (12.66%)  4/33 (12.12%)  0/6 (0.00%) 
C-reactive protein increased  1  3/79 (3.80%)  2/33 (6.06%)  0/6 (0.00%) 
Carbon monoxide diffusing capacity decreased  1  7/79 (8.86%)  1/33 (3.03%)  0/6 (0.00%) 
Gamma-glutamyltransferase increased  1  5/79 (6.33%)  1/33 (3.03%)  0/6 (0.00%) 
Haemoglobin decreased  1  11/79 (13.92%)  3/33 (9.09%)  0/6 (0.00%) 
International normalised ratio increased  1  4/79 (5.06%)  3/33 (9.09%)  0/6 (0.00%) 
Low density lipoprotein increased  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Weight decreased  1  7/79 (8.86%)  4/33 (12.12%)  0/6 (0.00%) 
Weight increased  1  4/79 (5.06%)  0/33 (0.00%)  0/6 (0.00%) 
White blood cell count decreased  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  8/79 (10.13%)  6/33 (18.18%)  0/6 (0.00%) 
Hypercholesterolaemia  1  29/79 (36.71%)  11/33 (33.33%)  0/6 (0.00%) 
Hyperglycaemia  1  3/79 (3.80%)  4/33 (12.12%)  0/6 (0.00%) 
Hyperlipidaemia  1  10/79 (12.66%)  5/33 (15.15%)  0/6 (0.00%) 
Hypertriglyceridaemia  1  8/79 (10.13%)  4/33 (12.12%)  0/6 (0.00%) 
Hypokalaemia  1  2/79 (2.53%)  5/33 (15.15%)  0/6 (0.00%) 
Hypophosphataemia  1  15/79 (18.99%)  4/33 (12.12%)  0/6 (0.00%) 
Iron deficiency  1  7/79 (8.86%)  1/33 (3.03%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  13/79 (16.46%)  3/33 (9.09%)  0/6 (0.00%) 
Back pain  1  12/79 (15.19%)  14/33 (42.42%)  0/6 (0.00%) 
Flank pain  1  5/79 (6.33%)  5/33 (15.15%)  1/6 (16.67%) 
Muscle spasms  1  2/79 (2.53%)  2/33 (6.06%)  1/6 (16.67%) 
Musculoskeletal chest pain  1  1/79 (1.27%)  4/33 (12.12%)  0/6 (0.00%) 
Musculoskeletal pain  1  2/79 (2.53%)  2/33 (6.06%)  0/6 (0.00%) 
Myalgia  1  7/79 (8.86%)  5/33 (15.15%)  1/6 (16.67%) 
Neck pain  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Pain in extremity  1  5/79 (6.33%)  7/33 (21.21%)  0/6 (0.00%) 
Nervous system disorders       
Convulsion  1  8/79 (10.13%)  4/33 (12.12%)  0/6 (0.00%) 
Dizziness  1  9/79 (11.39%)  4/33 (12.12%)  1/6 (16.67%) 
Epilepsy  1  3/79 (3.80%)  2/33 (6.06%)  0/6 (0.00%) 
Headache  1  26/79 (32.91%)  15/33 (45.45%)  0/6 (0.00%) 
Lethargy  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Migraine  1  9/79 (11.39%)  1/33 (3.03%)  0/6 (0.00%) 
Peripheral sensory neuropathy  1  0/79 (0.00%)  3/33 (9.09%)  0/6 (0.00%) 
Petit mal epilepsy  1  4/79 (5.06%)  2/33 (6.06%)  0/6 (0.00%) 
Psychiatric disorders       
Affective disorder  1  0/79 (0.00%)  2/33 (6.06%)  0/6 (0.00%) 
Aggression  1  1/79 (1.27%)  3/33 (9.09%)  0/6 (0.00%) 
Anxiety  1  4/79 (5.06%)  1/33 (3.03%)  0/6 (0.00%) 
Depression  1  8/79 (10.13%)  4/33 (12.12%)  0/6 (0.00%) 
Insomnia  1  6/79 (7.59%)  1/33 (3.03%)  0/6 (0.00%) 
Mood swings  1  3/79 (3.80%)  2/33 (6.06%)  0/6 (0.00%) 
Sleep disorder  1  2/79 (2.53%)  3/33 (9.09%)  0/6 (0.00%) 
Renal and urinary disorders       
Haematuria  1  2/79 (2.53%)  3/33 (9.09%)  1/6 (16.67%) 
Leukocyturia  1  0/79 (0.00%)  2/33 (6.06%)  0/6 (0.00%) 
Proteinuria  1  11/79 (13.92%)  10/33 (30.30%)  0/6 (0.00%) 
Renal pain  1  0/79 (0.00%)  2/33 (6.06%)  0/6 (0.00%) 
Reproductive system and breast disorders       
Amenorrhoea  1  16/79 (20.25%)  6/33 (18.18%)  0/6 (0.00%) 
Dysmenorrhoea  1  3/79 (3.80%)  1/33 (3.03%)  1/6 (16.67%) 
Menorrhagia  1  11/79 (13.92%)  2/33 (6.06%)  0/6 (0.00%) 
Menstruation irregular  1  11/79 (13.92%)  4/33 (12.12%)  0/6 (0.00%) 
Metrorrhagia  1  4/79 (5.06%)  3/33 (9.09%)  0/6 (0.00%) 
Ovarian cyst  1  5/79 (6.33%)  3/33 (9.09%)  0/6 (0.00%) 
Vaginal haemorrhage  1  7/79 (8.86%)  5/33 (15.15%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  2/79 (2.53%)  2/33 (6.06%)  0/6 (0.00%) 
Cough  1  21/79 (26.58%)  7/33 (21.21%)  2/6 (33.33%) 
Dyspnoea  1  3/79 (3.80%)  3/33 (9.09%)  0/6 (0.00%) 
Epistaxis  1  10/79 (12.66%)  3/33 (9.09%)  0/6 (0.00%) 
Lymphangioleiomyomatosis  1  1/79 (1.27%)  1/33 (3.03%)  1/6 (16.67%) 
Nasal congestion  1  2/79 (2.53%)  1/33 (3.03%)  1/6 (16.67%) 
Oropharyngeal pain  1  13/79 (16.46%)  6/33 (18.18%)  1/6 (16.67%) 
Pneumothorax  1  0/79 (0.00%)  2/33 (6.06%)  0/6 (0.00%) 
Productive cough  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Rhinitis allergic  1  2/79 (2.53%)  3/33 (9.09%)  0/6 (0.00%) 
Rhinorrhoea  1  4/79 (5.06%)  0/33 (0.00%)  0/6 (0.00%) 
Sinus congestion  1  2/79 (2.53%)  1/33 (3.03%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders       
Acne  1  25/79 (31.65%)  11/33 (33.33%)  0/6 (0.00%) 
Alopecia  1  7/79 (8.86%)  2/33 (6.06%)  0/6 (0.00%) 
Dermatitis  1  4/79 (5.06%)  1/33 (3.03%)  0/6 (0.00%) 
Dermatitis acneiform  1  6/79 (7.59%)  1/33 (3.03%)  0/6 (0.00%) 
Dry skin  1  8/79 (10.13%)  5/33 (15.15%)  0/6 (0.00%) 
Eczema  1  11/79 (13.92%)  3/33 (9.09%)  0/6 (0.00%) 
Papule  1  4/79 (5.06%)  2/33 (6.06%)  0/6 (0.00%) 
Pigmentation disorder  1  4/79 (5.06%)  2/33 (6.06%)  0/6 (0.00%) 
Pruritus  1  8/79 (10.13%)  5/33 (15.15%)  0/6 (0.00%) 
Rash  1  5/79 (6.33%)  3/33 (9.09%)  0/6 (0.00%) 
Rash pruritic  1  1/79 (1.27%)  2/33 (6.06%)  0/6 (0.00%) 
Skin mass  1  0/79 (0.00%)  2/33 (6.06%)  0/6 (0.00%) 
Vascular disorders       
Circulatory collapse  1  2/79 (2.53%)  2/33 (6.06%)  0/6 (0.00%) 
Haematoma  1  2/79 (2.53%)  2/33 (6.06%)  0/6 (0.00%) 
Hypertension  1  22/79 (27.85%)  12/33 (36.36%)  0/6 (0.00%) 
Lymphoedema  1  4/79 (5.06%)  2/33 (6.06%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Novartis Pharmaceuticals
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00790400     History of Changes
Other Study ID Numbers: CRAD001M2302
2008-002113-48 ( EudraCT Number )
First Submitted: November 10, 2008
First Posted: November 13, 2008
Results First Submitted: May 23, 2012
Results First Posted: August 28, 2012
Last Update Posted: February 17, 2017