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Trial record 80 of 1296 for:    survival | Neuroendocrine Tumors

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) (RADIANT-4)

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ClinicalTrials.gov Identifier: NCT01524783
Recruitment Status : Active, not recruiting
First Posted : February 2, 2012
Results First Posted : December 28, 2016
Last Update Posted : May 9, 2019
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 Advanced NET of GI Origin
Advanced NET of Lung Origin
Neuroendocrine Tumors
Interventions Drug: Everolimus
Drug: Everolimus Placebo
Enrollment 302
Recruitment Details 205 patients were randomized but only 203 patients received study drug. (Two patients randomized to everolimus were not treated due to withdrawal of consent and protocol deviation and one patient randomized to everolimus inadvertently received placebo treatment).
Pre-assignment Details  
Arm/Group Title Everolimus + BSC Everolimus Placebo + BSC
Hide Arm/Group Description Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC) Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
Period Title: Randomized But Not Treated
Started 205 97
Completed 203 [1] 97 [1]
Not Completed 2 0
Reason Not Completed
Randomized, did not receive drug             2             0
[1]
Completed = Participants randomized and treated with study drug
Period Title: Randomized and Treated
Started 203 97
Completed 48 [1] 13 [1]
Not Completed 155 84
Reason Not Completed
Adverse Event             59             7
Disease Progression             76             70
Withdrawal by Subject             15             5
Protocol Violation             1             1
Death             4             1
[1]
Completed = Patients with ongoing treatment at the time of data cut-off of 28-Nov-2014.
Arm/Group Title Everolimus + BSC Everolimus Placebo + BSC Total
Hide Arm/Group Description Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC) Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC) Total of all reporting groups
Overall Number of Baseline Participants 205 97 302
Hide Baseline Analysis Population Description
The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 205 participants 97 participants 302 participants
62.9  (11.70) 59.4  (12.89) 61.7  (12.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 97 participants 302 participants
Female
116
  56.6%
44
  45.4%
160
  53.0%
Male
89
  43.4%
53
  54.6%
142
  47.0%
1.Primary Outcome
Title Progression Free Survival (PFS) Based on Central Radiology Assessment Per Kaplan-Meier
Hide Description PFS is defined as the time from randomization to the date of the first documented tumor progression as per modified RECIST 1.0 or death from any cause, whichever comes first. Progression is assessed by cat scan (CT) and/or magnetic resonance imaging (MRI).
Time Frame From date of randomization to progression or death up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
Arm/Group Title Everolimus + BSC Everolimus Placebo + BSC
Hide Arm/Group Description:
Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
Overall Number of Participants Analyzed 205 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2 months
90.1
(84.8 to 93.5)
74.6
(64.3 to 82.4)
4 months
81.2
(74.9 to 86.2)
49.1
(38.1 to 59.2)
6 months
72.1
(65.0 to 78.0)
40.1
(29.5 to 50.0)
8 months
62.4
(54.8 to 69.1)
35.8
(25.4 to 46.2)
10 months
51.7
(44.0 to 59.0)
31.3
(21.3 to 41.7)
12 months
44.4
(36.7 to 51.8)
28.1
(18.5 to 38.6)
15 months
40.1
(32.5 to 47.6)
26.4
(16.9 to 36.8)
18 months
31.8
(24.1 to 39.8)
24.4
(15.0 to 34.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Everolimus + BSC, Everolimus Placebo + BSC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.35 to 0.67
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS) Using Kaplan-Meier
Hide Description OS is defined as the time from the date of randomization to date of death due to any cause.
Time Frame Every visit from randomization up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
Arm/Group Title Everolimus + BSC Everolimus Placebo + BSC
Hide Arm/Group Description:
Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
Overall Number of Participants Analyzed 205 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
3 months
98.0
(94.7 to 99.2)
97.9
(91.9 to 99.5)
6 months
94.9
(90.6 to 97.2)
90.3
(82.2 to 94.8)
9 months
92.7
(88.0 to 95.6)
84.6
(75.3 to 90.6)
12 months
88.8
(83.4 to 92.6)
82.2
(72.6 to 88.7)
15 months
84.3
(78.1 to 88.8)
77.2
(66.9 to 84.7)
18 months
80.6
(73.8 to 85.8)
72.8
(61.7 to 81.1)
3.Secondary Outcome
Title Overall Safety Evaluation of Everolimus Versus Placebo
Hide Description The assessment of safety will be based mainly on the frequency and type of treatment emergent adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g. vital signs) will be considered as appropriate. Safety events will be graded using the CTCAE V4.03 (Common Terminology Criteria for Adverse Events).
Time Frame Every visit from randomization up to 5 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title FACT-G Total Score Over the Duration of the Study
Hide Description FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions, scored 0 to 4, examining physical, social/family, emotional, and functional well-being. Deterioration is defined as a decrease by at least 7 points compared to baseline.
Time Frame Every Visit from randomization up to 5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR will be assessed per modified RECIST 1.0. ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR).
Time Frame Every Visit from randomization up to 5 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description The estimated average treatment duration is at least 5-8.5 months until disease progression. DCR will be assessed per modified RECIST 1.0. DCR is the proportion of patients with best overall response of CR, PR or stable disease (SD).
Time Frame 5 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change in Chromogranin A (CgA) and Neuron Specific Enolase (NSE) Levels During the Study
Hide Description The estimated average treatment duration is at least 5-8.5 months until disease progression. CgA and NSE are potential biomarkers for tumor response. Change from baseline will be noted and correlated with tumor response.
Time Frame Every visit from baseline up to 5 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Time to Definitive Deterioration in WHO Performance Status Change During the Study
Hide Description The estimated average duration is at least 5-8.5 months until disease progression. WHO Performance Status is a scale rated from 0 (normal) to 5 (dead) by a healthcare professional to assess the overall status of a patient. Deterioration is defined as an increase of at least one category compared to baseline.
Time Frame Every visit up from randomization to 5 years
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Pharmacokinetics (PK)
Hide Description A single blood sample to determine the exposure of everolimus at the steady-state pre-dose concentration (Cmin).
Time Frame Visit 3 (Cycle 2, Study Day 29)
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Everolimus + BSC Placebo + BSC
Hide Arm/Group Description Everolimus + BSC Placebo + BSC
All-Cause Mortality
Everolimus + BSC Placebo + BSC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Everolimus + BSC Placebo + BSC
Affected / at Risk (%) Affected / at Risk (%)
Total   85/202 (42.08%)   19/98 (19.39%) 
Blood and lymphatic system disorders     
Anaemia  1  6/202 (2.97%)  0/98 (0.00%) 
Thrombocytopenia  1  1/202 (0.50%)  0/98 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/202 (0.50%)  0/98 (0.00%) 
Atrial fibrillation  1  1/202 (0.50%)  0/98 (0.00%) 
Cardiac failure  1  3/202 (1.49%)  0/98 (0.00%) 
Cardiac failure chronic  1  1/202 (0.50%)  0/98 (0.00%) 
Cardiac failure congestive  1  2/202 (0.99%)  0/98 (0.00%) 
Cardiovascular disorder  1  1/202 (0.50%)  0/98 (0.00%) 
Myocardial infarction  1  1/202 (0.50%)  0/98 (0.00%) 
Pericardial effusion  1  1/202 (0.50%)  0/98 (0.00%) 
Tachycardia  1  1/202 (0.50%)  0/98 (0.00%) 
Eye disorders     
Blindness unilateral  1  0/202 (0.00%)  1/98 (1.02%) 
Gastrointestinal disorders     
Abdominal pain  1  11/202 (5.45%)  4/98 (4.08%) 
Ascites  1  1/202 (0.50%)  1/98 (1.02%) 
Colitis  1  1/202 (0.50%)  0/98 (0.00%) 
Constipation  1  1/202 (0.50%)  0/98 (0.00%) 
Diarrhoea  1  8/202 (3.96%)  0/98 (0.00%) 
Enterocolitis  1  1/202 (0.50%)  0/98 (0.00%) 
Gastric ulcer  1  1/202 (0.50%)  0/98 (0.00%) 
Gastrointestinal haemorrhage  1  2/202 (0.99%)  0/98 (0.00%) 
Gastrointestinal oedema  1  1/202 (0.50%)  0/98 (0.00%) 
Ileus  1  1/202 (0.50%)  1/98 (1.02%) 
Intestinal obstruction  1  2/202 (0.99%)  1/98 (1.02%) 
Intestinal perforation  1  1/202 (0.50%)  0/98 (0.00%) 
Jejunal perforation  1  1/202 (0.50%)  0/98 (0.00%) 
Nausea  1  3/202 (1.49%)  1/98 (1.02%) 
Pancreatic necrosis  1  0/202 (0.00%)  1/98 (1.02%) 
Pancreatitis  1  0/202 (0.00%)  1/98 (1.02%) 
Small intestinal obstruction  1  6/202 (2.97%)  0/98 (0.00%) 
Small intestinal perforation  1  0/202 (0.00%)  1/98 (1.02%) 
Subileus  1  2/202 (0.99%)  0/98 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/202 (0.50%)  0/98 (0.00%) 
Vomiting  1  5/202 (2.48%)  2/98 (2.04%) 
General disorders     
Asthenia  1  5/202 (2.48%)  0/98 (0.00%) 
Chest discomfort  1  1/202 (0.50%)  0/98 (0.00%) 
Chills  1  1/202 (0.50%)  0/98 (0.00%) 
Fatigue  1  5/202 (2.48%)  0/98 (0.00%) 
Non-cardiac chest pain  1  0/202 (0.00%)  2/98 (2.04%) 
Oedema peripheral  1  1/202 (0.50%)  1/98 (1.02%) 
Organ failure  1  1/202 (0.50%)  0/98 (0.00%) 
Performance status decreased  1  1/202 (0.50%)  0/98 (0.00%) 
Pyrexia  1  9/202 (4.46%)  1/98 (1.02%) 
Hepatobiliary disorders     
Bile duct stone  1  1/202 (0.50%)  1/98 (1.02%) 
Cholangitis  1  2/202 (0.99%)  0/98 (0.00%) 
Cholecystitis  1  3/202 (1.49%)  0/98 (0.00%) 
Cholelithiasis  1  2/202 (0.99%)  1/98 (1.02%) 
Hepatic failure  1  2/202 (0.99%)  0/98 (0.00%) 
Hepatic pain  1  1/202 (0.50%)  0/98 (0.00%) 
Immune system disorders     
Contrast media allergy  1  1/202 (0.50%)  0/98 (0.00%) 
Infections and infestations     
Bronchopulmonary aspergillosis  1  1/202 (0.50%)  0/98 (0.00%) 
Campylobacter gastroenteritis  1  1/202 (0.50%)  0/98 (0.00%) 
Clostridium difficile infection  1  1/202 (0.50%)  0/98 (0.00%) 
Device related infection  1  1/202 (0.50%)  0/98 (0.00%) 
Infection  1  1/202 (0.50%)  0/98 (0.00%) 
Lobar pneumonia  1  1/202 (0.50%)  0/98 (0.00%) 
Lower respiratory tract infection  1  2/202 (0.99%)  0/98 (0.00%) 
Lung infection  1  0/202 (0.00%)  1/98 (1.02%) 
Peritonitis  1  1/202 (0.50%)  0/98 (0.00%) 
Pneumonia  1  6/202 (2.97%)  0/98 (0.00%) 
Pneumonia bacterial  1  1/202 (0.50%)  0/98 (0.00%) 
Post procedural cellulitis  1  1/202 (0.50%)  0/98 (0.00%) 
Respiratory tract infection  1  1/202 (0.50%)  0/98 (0.00%) 
Salmonellosis  1  1/202 (0.50%)  0/98 (0.00%) 
Sepsis  1  1/202 (0.50%)  0/98 (0.00%) 
Septic shock  1  2/202 (0.99%)  0/98 (0.00%) 
Upper respiratory tract infection  1  1/202 (0.50%)  0/98 (0.00%) 
Urinary tract infection  1  3/202 (1.49%)  0/98 (0.00%) 
Urosepsis  1  1/202 (0.50%)  0/98 (0.00%) 
Viral myocarditis  1  1/202 (0.50%)  0/98 (0.00%) 
Injury, poisoning and procedural complications     
Facial bones fracture  1  0/202 (0.00%)  1/98 (1.02%) 
Incisional hernia  1  1/202 (0.50%)  0/98 (0.00%) 
Investigations     
Ejection fraction decreased  1  2/202 (0.99%)  0/98 (0.00%) 
Gamma-glutamyltransferase increased  1  2/202 (0.99%)  0/98 (0.00%) 
Gastrointestinal stoma output decreased  1  1/202 (0.50%)  0/98 (0.00%) 
Troponin increased  1  1/202 (0.50%)  0/98 (0.00%) 
Weight decreased  1  1/202 (0.50%)  0/98 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/202 (0.50%)  0/98 (0.00%) 
Dehydration  1  2/202 (0.99%)  1/98 (1.02%) 
Diabetes mellitus  1  1/202 (0.50%)  0/98 (0.00%) 
Hyperglycaemia  1  2/202 (0.99%)  0/98 (0.00%) 
Hypoalbuminaemia  1  1/202 (0.50%)  0/98 (0.00%) 
Hypocalcaemia  1  1/202 (0.50%)  0/98 (0.00%) 
Hypoglycaemia  1  1/202 (0.50%)  0/98 (0.00%) 
Hypokalaemia  1  3/202 (1.49%)  0/98 (0.00%) 
Hyponatraemia  1  1/202 (0.50%)  0/98 (0.00%) 
Hypovolaemia  1  1/202 (0.50%)  0/98 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/202 (0.99%)  0/98 (0.00%) 
Flank pain  1  1/202 (0.50%)  0/98 (0.00%) 
Musculoskeletal pain  1  1/202 (0.50%)  0/98 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer recurrent  1  1/202 (0.50%)  0/98 (0.00%) 
Cancer pain  1  0/202 (0.00%)  1/98 (1.02%) 
Pituitary tumour benign  1  1/202 (0.50%)  0/98 (0.00%) 
Prostate cancer  1  1/202 (0.50%)  0/98 (0.00%) 
Tumour associated fever  1  1/202 (0.50%)  0/98 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage  1  1/202 (0.50%)  1/98 (1.02%) 
Convulsion  1  1/202 (0.50%)  0/98 (0.00%) 
Disturbance in attention  1  1/202 (0.50%)  0/98 (0.00%) 
Dysarthria  1  1/202 (0.50%)  0/98 (0.00%) 
Epilepsy  1  1/202 (0.50%)  0/98 (0.00%) 
Headache  1  1/202 (0.50%)  0/98 (0.00%) 
Intracranial pressure increased  1  0/202 (0.00%)  1/98 (1.02%) 
Somnolence  1  1/202 (0.50%)  0/98 (0.00%) 
Psychiatric disorders     
Anxiety  1  0/202 (0.00%)  1/98 (1.02%) 
Confusional state  1  0/202 (0.00%)  1/98 (1.02%) 
Delirium  1  1/202 (0.50%)  0/98 (0.00%) 
Mental disorder  1  1/202 (0.50%)  0/98 (0.00%) 
Panic attack  1  0/202 (0.00%)  1/98 (1.02%) 
Renal and urinary disorders     
Hydronephrosis  1  1/202 (0.50%)  0/98 (0.00%) 
Nephrolithiasis  1  1/202 (0.50%)  0/98 (0.00%) 
Renal failure acute  1  3/202 (1.49%)  3/98 (3.06%) 
Renal impairment  1  1/202 (0.50%)  0/98 (0.00%) 
Urinary tract obstruction  1  1/202 (0.50%)  0/98 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/202 (0.50%)  0/98 (0.00%) 
Dyspnoea  1  3/202 (1.49%)  1/98 (1.02%) 
Interstitial lung disease  1  1/202 (0.50%)  0/98 (0.00%) 
Obliterative bronchiolitis  1  1/202 (0.50%)  0/98 (0.00%) 
Pleural effusion  1  3/202 (1.49%)  0/98 (0.00%) 
Pneumonitis  1  4/202 (1.98%)  0/98 (0.00%) 
Pneumothorax  1  2/202 (0.99%)  0/98 (0.00%) 
Pulmonary embolism  1  2/202 (0.99%)  0/98 (0.00%) 
Respiratory failure  1  2/202 (0.99%)  1/98 (1.02%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/202 (0.50%)  0/98 (0.00%) 
Drug eruption  1  1/202 (0.50%)  0/98 (0.00%) 
Hyperhidrosis  1  1/202 (0.50%)  0/98 (0.00%) 
Toxic skin eruption  1  1/202 (0.50%)  0/98 (0.00%) 
Vascular disorders     
Aortic stenosis  1  0/202 (0.00%)  1/98 (1.02%) 
Hypertension  1  1/202 (0.50%)  0/98 (0.00%) 
Hypotension  1  2/202 (0.99%)  0/98 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Everolimus + BSC Placebo + BSC
Affected / at Risk (%) Affected / at Risk (%)
Total   195/202 (96.53%)   81/98 (82.65%) 
Blood and lymphatic system disorders     
Anaemia  1  43/202 (21.29%)  9/98 (9.18%) 
Gastrointestinal disorders     
Abdominal discomfort  1  0/202 (0.00%)  7/98 (7.14%) 
Abdominal pain  1  34/202 (16.83%)  17/98 (17.35%) 
Abdominal pain upper  1  19/202 (9.41%)  11/98 (11.22%) 
Constipation  1  20/202 (9.90%)  18/98 (18.37%) 
Diarrhoea  1  82/202 (40.59%)  30/98 (30.61%) 
Dry mouth  1  18/202 (8.91%)  5/98 (5.10%) 
Dyspepsia  1  10/202 (4.95%)  5/98 (5.10%) 
Mouth ulceration  1  18/202 (8.91%)  1/98 (1.02%) 
Nausea  1  52/202 (25.74%)  16/98 (16.33%) 
Stomatitis  1  111/202 (54.95%)  19/98 (19.39%) 
Vomiting  1  28/202 (13.86%)  10/98 (10.20%) 
General disorders     
Asthenia  1  43/202 (21.29%)  8/98 (8.16%) 
Fatigue  1  73/202 (36.14%)  35/98 (35.71%) 
Oedema peripheral  1  77/202 (38.12%)  5/98 (5.10%) 
Pyrexia  1  39/202 (19.31%)  8/98 (8.16%) 
Infections and infestations     
Nasopharyngitis  1  18/202 (8.91%)  4/98 (4.08%) 
Upper respiratory tract infection  1  15/202 (7.43%)  6/98 (6.12%) 
Urinary tract infection  1  20/202 (9.90%)  5/98 (5.10%) 
Investigations     
Alanine aminotransferase increased  1  11/202 (5.45%)  2/98 (2.04%) 
Blood alkaline phosphatase increased  1  3/202 (1.49%)  5/98 (5.10%) 
Weight decreased  1  44/202 (21.78%)  11/98 (11.22%) 
Metabolism and nutrition disorders     
Decreased appetite  1  44/202 (21.78%)  17/98 (17.35%) 
Hypercholesterolaemia  1  13/202 (6.44%)  2/98 (2.04%) 
Hyperglycaemia  1  24/202 (11.88%)  3/98 (3.06%) 
Hypertriglyceridaemia  1  11/202 (5.45%)  0/98 (0.00%) 
Hypokalaemia  1  19/202 (9.41%)  4/98 (4.08%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  24/202 (11.88%)  8/98 (8.16%) 
Back pain  1  26/202 (12.87%)  14/98 (14.29%) 
Myalgia  1  12/202 (5.94%)  3/98 (3.06%) 
Pain in extremity  1  18/202 (8.91%)  5/98 (5.10%) 
Nervous system disorders     
Dizziness  1  10/202 (4.95%)  5/98 (5.10%) 
Dysgeusia  1  37/202 (18.32%)  4/98 (4.08%) 
Headache  1  24/202 (11.88%)  15/98 (15.31%) 
Psychiatric disorders     
Insomnia  1  20/202 (9.90%)  7/98 (7.14%) 
Renal and urinary disorders     
Proteinuria  1  16/202 (7.92%)  2/98 (2.04%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  54/202 (26.73%)  20/98 (20.41%) 
Dyspnoea  1  38/202 (18.81%)  11/98 (11.22%) 
Epistaxis  1  26/202 (12.87%)  3/98 (3.06%) 
Oropharyngeal pain  1  12/202 (5.94%)  3/98 (3.06%) 
Pneumonitis  1  26/202 (12.87%)  2/98 (2.04%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  19/202 (9.41%)  3/98 (3.06%) 
Dry skin  1  18/202 (8.91%)  2/98 (2.04%) 
Erythema  1  12/202 (5.94%)  2/98 (2.04%) 
Nail disorder  1  13/202 (6.44%)  0/98 (0.00%) 
Pruritus  1  35/202 (17.33%)  9/98 (9.18%) 
Rash  1  61/202 (30.20%)  9/98 (9.18%) 
Vascular disorders     
Hypertension  1  23/202 (11.39%)  8/98 (8.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Two patients randomized to everolimus were not treated due to withdrawal of consent and protocol deviation and one patient randomized to everolimus inadvertently received placebo treatment.
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01524783     History of Changes
Other Study ID Numbers: CRAD001T2302
2011-002887-26 ( Registry Identifier: EudraCT )
First Submitted: December 22, 2011
First Posted: February 2, 2012
Results First Submitted: March 26, 2016
Results First Posted: December 28, 2016
Last Update Posted: May 9, 2019