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Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop) (ENESTop)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01698905
Recruitment Status : Active, not recruiting
First Posted : October 3, 2012
Results First Posted : January 13, 2021
Last Update Posted : March 21, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Myeloid Leukemia
Intervention Drug: nilotinib
Enrollment 163
Recruitment Details A total of 163 patients were enrolled into this study. 126 of the 163 patients who completed 52 weeks of nilotinib treatment in the NTCS phase entered the TFR phase and were part of the Full analysis Set (FAS).
Pre-assignment Details Approximately 117 patients were planned to be enrolled into this study.
Arm/Group Title NTCS Phase
Hide Arm/Group Description Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
Period Title: Overall Study
Started 163
Still on Study Phase 0
TFR Phase 126
NTRI Phase 51
NTCT Phase 26
TFR-2 Phase 2
NTRI-2 Phase 1
NTCT-P Phase Phase 6
Completed [1] 152
Not Completed 11
Reason Not Completed
Adverse Event             4
Physician Decision             2
Pregnancy             1
Protocol Violation             1
Subject/guardian decision             2
Death             1
[1]
Completed = Completed 52 weeks of NTCS phase
Arm/Group Title NTCS Phase
Hide Arm/Group Description Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
Overall Number of Baseline Participants 163
Hide Baseline Analysis Population Description
Safety Set: The safety set included all patients who received at least one dose of study medication in the Consolidation Phase.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants
54.3  (13.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants
Female
86
  52.8%
Male
77
  47.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 163 participants
Caucasian 127
Black 6
Asian 23
Native American 1
Other 6
1.Primary Outcome
Title Percentage of Patients in Treatment Free Remission (TFR) Within 48 Weeks
Hide Description TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL > 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 48 weeks after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, and multiplied by 100.
Time Frame First 48 weeks following nilotinib cessation.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): FAS included all patients who entered the TFR phase.
Arm/Group Title NTCS Phase
Hide Arm/Group Description:
Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
Overall Number of Participants Analyzed 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
57.9
(48.8 to 66.7)
2.Secondary Outcome
Title Percentage of Patients in Treatment Free Remission (TFR) Within 96, 144, 192, 264 Weeks and Within 6,7,8,9 and 10 Years
Hide Description TFR is defined as no confirmed loss of MR4 (molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL > 0.01% IS. Loss of MMR does not require confirmation. Percentage of patients in TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase, multiplied by 100.
Time Frame 96, 144, 192, 264 weeks and within 6,7,8,9 and 10 years following nilotinib cessation
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Progression Free Survival (PFS) to Accelerated Phase/Blast Crisis (AP/BC) or Death
Hide Description Kaplan-Meier (KM) estimation of PFS. PFS is measured from the date of start of nilotinib TFR phase (cessation of nilotinib) to the date of the earliest of the event: progression to AP/BC, or death from any cause. Patients not known to have recurred or died on or before the cut-off date for the KM analysis will have their PFS interval right-censored at the earlier of the date of their last assessment (cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up.
Time Frame nilotinib cessation up to approximately 580 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Treatment Free Survival (TFS)
Hide Description Kaplan-Meier (KM) estimation of TFS is measured from the date of the start of the nilotinib TFR phase to the date of the earliest of the following: loss of MMR, confirmed loss of MR4, re-start of nilotinib treatment, progression to AP/BC or death from any cause. Patients not known to have had any of the events or died on or before the cut-off date for the KM analysis will have their TFS interval right-censored at the earlier of the date of their last assessment (PCR, cytogenetic, hematology or extramedullary) for patients who are still on study and at the date of last contact for patients are in follow-up. A TFS sensitivity analysis will be conducted by considering discontinuation from TFR phase due to any reason as an event, in addition to the events as defined above
Time Frame nilotinib cessation up to approximately 580 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Kaplan-Meier (KM) estimation of OS. OS is measured from the date of start of nilotinib TFR phase to the date of death from any cause. If a patient is not known to have died, survival will be censored at the date of last contact.
Time Frame nilotinib cessation up to approximately 580 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in BCR-ABL (Oncoprotein Product of BCR-ABL Fusion Gene) Transcripts After Re-start of Nilotinib Therapy
Hide Description Descriptive statistics of BCR-ABL over time after re-start of nilotinib therapy. ABL= Abelson leukemia virus and BCR=Break point cluster region
Time Frame re-start of nilotinib up to approximately 48 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percentage of Patients With Stable MMR in Nilotinib Re-initiation Phase
Hide Description Percentage of patients who are in stable MMR (stable MMR=BCR-ABL ≤ 0.1% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MMR any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MMR, irrespective of whether there is loss of MMR in between, by the number of patients who achieved MMR at any time during the nilotinib re-initiation phase, and multiplied by 100.
Time Frame start of nilotinib in re-initiation phase up to approximately 432 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Patients With Stable MR4 in Nilotinib Re-initiation Phase
Hide Description Percentage of patients who are in stable MR4 (stable MR4=BCR-ABL ≤ 0.01% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4, irrespective of whether there is loss of MR4 in between, by the number of patients who achieved MR4 at any time during the nilotinib re-initiation phase, and multiplied by 100.
Time Frame start of nilotinib in re-initiation phase up to approximately 432 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percentage of Patients With Stable MR4.5 in Nilotinib Re-initiation Phase
Hide Description Percentage of patients who are in stable MR4.5 (stable MR4.5=BCR-ABL ≤ 0.0032% IS) at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after achievement of that response in the nilotinib re-initiation phase for 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks is calculated by dividing the number of patients achieving MR4.5 any time during the nilotinib re-initiation phase and having the same response at 48, 96, 144, 192, 240, 288, 336, 384, and 432 weeks after the first achievement of MR4.5, irrespective of whether there is loss of MR4.5 in between, by the number of patients who achieved MR4.5 at any time during the nilotinib re-initiation phase, multiplied by 100.
Time Frame start of nilotinib in re-initiation phase up to approximately 432 weeks
Outcome Measure Data Not Reported
Time Frame Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Adverse Event Reporting Description Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
 
Arm/Group Title NTCS Phase TFR Phase NTRI Phase NTCT Phase TFR-2 Phase NTRI-2 Phase NTCT-P Phase All Patients
Hide Arm/Group Description Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening treatment-free remission nilotinib treatment re-initiation nilotinib treatment continuation treatment-free remission 2 nilotinib treatment re-initiation 2 nilotinib treatment prolonged continuation All patients enrolled in the study
All-Cause Mortality
NTCS Phase TFR Phase NTRI Phase NTCT Phase TFR-2 Phase NTRI-2 Phase NTCT-P Phase All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/163 (0.61%)   0/126 (0.00%)   0/51 (0.00%)   0/26 (0.00%)   0/2 (0.00%)   0/1 (0.00%)   0/6 (0.00%)   1/163 (0.61%) 
Hide Serious Adverse Events
NTCS Phase TFR Phase NTRI Phase NTCT Phase TFR-2 Phase NTRI-2 Phase NTCT-P Phase All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/163 (12.88%)   8/126 (6.35%)   4/51 (7.84%)   3/26 (11.54%)   0/2 (0.00%)   0/1 (0.00%)   0/6 (0.00%)   34/163 (20.86%) 
Cardiac disorders                 
ACUTE MYOCARDIAL INFARCTION † 1  2/163 (1.23%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  2/163 (1.23%) 
ARRHYTHMIA † 1  0/163 (0.00%)  0/126 (0.00%)  1/51 (1.96%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
ATRIAL FIBRILLATION † 1  2/163 (1.23%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  2/163 (1.23%) 
ATRIOVENTRICULAR BLOCK † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
CARDIAC FAILURE CONGESTIVE † 1  0/163 (0.00%)  1/126 (0.79%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
CORONARY ARTERY DISEASE † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
SINUS TACHYCARDIA † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Gastrointestinal disorders                 
CONSTIPATION † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
DIARRHOEA † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
INTESTINAL OBSTRUCTION † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
General disorders                 
NECROSIS † 1  0/163 (0.00%)  0/126 (0.00%)  1/51 (1.96%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Infections and infestations                 
CELLULITIS † 1  1/163 (0.61%)  2/126 (1.59%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  3/163 (1.84%) 
DIVERTICULITIS † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
GASTROENTERITIS † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
INFLUENZA † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
PNEUMONIA † 1  2/163 (1.23%)  1/126 (0.79%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  3/163 (1.84%) 
POST PROCEDURAL INFECTION † 1  0/163 (0.00%)  0/126 (0.00%)  0/51 (0.00%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Injury, poisoning and procedural complications                 
LIGAMENT SPRAIN † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Investigations                 
HAEMATOLOGY TEST ABNORMAL † 1  0/163 (0.00%)  1/126 (0.79%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
TRANSAMINASES INCREASED † 1  0/163 (0.00%)  0/126 (0.00%)  0/51 (0.00%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Metabolism and nutrition disorders                 
TYPE 2 DIABETES MELLITUS † 1  0/163 (0.00%)  1/126 (0.79%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Musculoskeletal and connective tissue disorders                 
BACK PAIN † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
MUSCLE SPASMS † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
PAIN IN EXTREMITY † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
ADENOCARCINOMA † 1  0/163 (0.00%)  0/126 (0.00%)  1/51 (1.96%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
LUNG ADENOCARCINOMA † 1  0/163 (0.00%)  1/126 (0.79%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
LYMPHOPROLIFERATIVE DISORDER † 1  0/163 (0.00%)  0/126 (0.00%)  1/51 (1.96%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
PROSTATE CANCER † 1  0/163 (0.00%)  1/126 (0.79%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
URETERIC CANCER † 1  0/163 (0.00%)  0/126 (0.00%)  0/51 (0.00%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Nervous system disorders                 
CARPAL TUNNEL SYNDROME † 1  0/163 (0.00%)  1/126 (0.79%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
CEREBRAL INFARCTION † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
CEREBROVASCULAR ACCIDENT † 1  0/163 (0.00%)  0/126 (0.00%)  0/51 (0.00%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
ISCHAEMIC STROKE † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Renal and urinary disorders                 
RENAL FAILURE † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Reproductive system and breast disorders                 
METRORRHAGIA † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Respiratory, thoracic and mediastinal disorders                 
ASTHMA † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
DYSPNOEA EXERTIONAL † 1  0/163 (0.00%)  0/126 (0.00%)  1/51 (1.96%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
PLEURAL FIBROSIS † 1  0/163 (0.00%)  0/126 (0.00%)  1/51 (1.96%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
Vascular disorders                 
ARTERIAL HAEMORRHAGE † 1  1/163 (0.61%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  1/163 (0.61%) 
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE † 1  2/163 (1.23%)  0/126 (0.00%)  1/51 (1.96%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  3/163 (1.84%) 
1
Term from vocabulary, MedDRA (18.1)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NTCS Phase TFR Phase NTRI Phase NTCT Phase TFR-2 Phase NTRI-2 Phase NTCT-P Phase All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   80/163 (49.08%)   70/126 (55.56%)   29/51 (56.86%)   11/26 (42.31%)   0/2 (0.00%)   0/1 (0.00%)   2/6 (33.33%)   122/163 (74.85%) 
Blood and lymphatic system disorders                 
ANAEMIA † 1  2/163 (1.23%)  2/126 (1.59%)  1/51 (1.96%)  2/26 (7.69%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  6/163 (3.68%) 
Gastrointestinal disorders                 
ABDOMINAL PAIN † 1  6/163 (3.68%)  2/126 (1.59%)  2/51 (3.92%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  10/163 (6.13%) 
ABDOMINAL PAIN LOWER † 1  0/163 (0.00%)  0/126 (0.00%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  1/6 (16.67%)  1/163 (0.61%) 
ABDOMINAL PAIN UPPER † 1  3/163 (1.84%)  3/126 (2.38%)  1/51 (1.96%)  2/26 (7.69%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  9/163 (5.52%) 
CONSTIPATION † 1  5/163 (3.07%)  0/126 (0.00%)  3/51 (5.88%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  8/163 (4.91%) 
DIARRHOEA † 1  4/163 (2.45%)  5/126 (3.97%)  1/51 (1.96%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  11/163 (6.75%) 
NAUSEA † 1  5/163 (3.07%)  2/126 (1.59%)  4/51 (7.84%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  9/163 (5.52%) 
General disorders                 
FATIGUE † 1  6/163 (3.68%)  3/126 (2.38%)  3/51 (5.88%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  12/163 (7.36%) 
Infections and infestations                 
NASOPHARYNGITIS † 1  10/163 (6.13%)  5/126 (3.97%)  3/51 (5.88%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  14/163 (8.59%) 
UPPER RESPIRATORY TRACT INFECTION † 1  7/163 (4.29%)  2/126 (1.59%)  3/51 (5.88%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  11/163 (6.75%) 
Investigations                 
WEIGHT INCREASED † 1  0/163 (0.00%)  11/126 (8.73%)  0/51 (0.00%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  11/163 (6.75%) 
Metabolism and nutrition disorders                 
DECREASED APPETITE † 1  2/163 (1.23%)  0/126 (0.00%)  3/51 (5.88%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  4/163 (2.45%) 
HYPERTRIGLYCERIDAEMIA † 1  1/163 (0.61%)  1/126 (0.79%)  3/51 (5.88%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  3/163 (1.84%) 
Musculoskeletal and connective tissue disorders                 
ARTHRALGIA † 1  8/163 (4.91%)  30/126 (23.81%)  6/51 (11.76%)  2/26 (7.69%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  43/163 (26.38%) 
MUSCLE SPASMS † 1  3/163 (1.84%)  2/126 (1.59%)  3/51 (5.88%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  7/163 (4.29%) 
MUSCULOSKELETAL PAIN † 1  3/163 (1.84%)  10/126 (7.94%)  2/51 (3.92%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  15/163 (9.20%) 
MYALGIA † 1  4/163 (2.45%)  17/126 (13.49%)  2/51 (3.92%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  23/163 (14.11%) 
PAIN IN EXTREMITY † 1  11/163 (6.75%)  9/126 (7.14%)  2/51 (3.92%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  21/163 (12.88%) 
Nervous system disorders                 
HEADACHE † 1  8/163 (4.91%)  5/126 (3.97%)  1/51 (1.96%)  2/26 (7.69%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  16/163 (9.82%) 
Respiratory, thoracic and mediastinal disorders                 
OROPHARYNGEAL PAIN † 1  3/163 (1.84%)  2/126 (1.59%)  1/51 (1.96%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  1/6 (16.67%)  6/163 (3.68%) 
Skin and subcutaneous tissue disorders                 
RASH † 1  7/163 (4.29%)  1/126 (0.79%)  4/51 (7.84%)  0/26 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  12/163 (7.36%) 
Vascular disorders                 
HYPERTENSION † 1  14/163 (8.59%)  7/126 (5.56%)  7/51 (13.73%)  1/26 (3.85%)  0/2 (0.00%)  0/1 (0.00%)  0/6 (0.00%)  22/163 (13.50%) 
1
Term from vocabulary, MedDRA (18.1)
†
Indicates events were collected by systematic assessment
[Not Specified]
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. 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01698905    
Other Study ID Numbers: CAMN107A2408
2012-003186-18 ( EudraCT Number )
First Submitted: October 1, 2012
First Posted: October 3, 2012
Results First Submitted: December 17, 2020
Results First Posted: January 13, 2021
Last Update Posted: March 21, 2022