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A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

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: NCT01379534
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : March 31, 2015
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Solid Tumors and Advanced Endometrial Cancer
Endometrial Cancer
Second-line Treatment
VEGF
Intervention Drug: TKI258
Enrollment 53
Recruitment Details Participants were treated with TKI258 until disease progression, unacceptable toxicity, death or discontinuation due to any other reason. All participants were followed for at least 30 days after their last dose of study drug for safety assessment.
Pre-assignment Details If a participant didn't discontinue study drug due to disease progression, death, lost to follow-up or withdrawn consent to post treatment tumor assessment, then tumor assessments continued every 6 weeks until the start of new anti-cancer therapy, disease progression, death, lost to follow-up or withdrawn consent to tumor status follow-up.
Arm/Group Title FGFR2 (MUT) FGFR2 (WT)
Hide Arm/Group Description Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks. Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Period Title: Treatment Phase
Started 22 31
Completed 0 0
Not Completed 22 31
Reason Not Completed
Withdrawal by Subject             2             2
Progressive disease             13             22
Adverse Event             7             7
Period Title: Tumor Assessment Follow-up (f/u) Phase
Started 4 [1] 2
Completed 0 0
Not Completed 4 2
Reason Not Completed
Death             0             1
Progressive disease             3             0
Lost to Follow-up             0             1
Adverse Event             1             0
[1]
All participants discontinued the Treatment Phase. Of these, only 6 qualified for f/u tumor assess..
Arm/Group Title FGFR2 (MUT) FGFR2 (WT) Total
Hide Arm/Group Description Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks. Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks. Total of all reporting groups
Overall Number of Baseline Participants 22 31 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 31 participants 53 participants
61.9  (10.54) 64.4  (8.63) 63.4  (9.45)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 31 participants 53 participants
22 31 53
[1]
Measure Description: Females only
1.Primary Outcome
Title Progression Free Survival (PFS) Rate
Hide Description The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time Frame up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.
Arm/Group Title FGFR2 (MUT) FGFR2 (WT)
Hide Arm/Group Description:
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Overall Number of Participants Analyzed 22 31
Measure Type: Number
Unit of Measure: Percentage of participants
31.8 29.0
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
Time Frame Baseline and every 6 weeks until disease progression, up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.
Arm/Group Title FGFR2 (MUT) FGFR2 (WT)
Hide Arm/Group Description:
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Overall Number of Participants Analyzed 22 31
Measure Type: Number
Unit of Measure: Percentage of participants
4.5 16.1
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
Time Frame Baseline and every 6 weeks until disease progression, up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.
Arm/Group Title FGFR2 (MUT) FGFR2 (WT)
Hide Arm/Group Description:
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Overall Number of Participants Analyzed 22 31
Measure Type: Number
Unit of Measure: Percentage of participants
63.6 51.6
4.Secondary Outcome
Title Duration of Response (DR)
Hide Description Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.
Time Frame up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed. The analysis was not required because there were too few responders.
Arm/Group Title FGFR2 (MUT) FGFR2 (WT)
Hide Arm/Group Description:
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.
Time Frame up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.
Arm/Group Title FGFR2 (MUT) FGFR2 (WT)
Hide Arm/Group Description:
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Overall Number of Participants Analyzed 22 31
Median (95% Confidence Interval)
Unit of Measure: Months
20.2
(8.2 to 20.2)
9.3
(6.0 to 15.2)
6.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.
Time Frame up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.
Arm/Group Title FGFR2 (MUT) FGFR2 (WT)
Hide Arm/Group Description:
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Overall Number of Participants Analyzed 22 31
Median (95% Confidence Interval)
Unit of Measure: Months
4.1
(2.6 to 5.5)
2.7
(1.4 to 6.8)
7.Secondary Outcome
Title Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Hide Description Adverse event monitoring was conducted throughout the study.
Time Frame up to 30 days after the last dose of study drug, up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: The safety set included all participants who received at least one dose of study medication.
Arm/Group Title FGFR2 (MUT) FGFR2 (WT)
Hide Arm/Group Description:
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
Overall Number of Participants Analyzed 22 31
Measure Type: Number
Unit of Measure: Participants
Adverse events (serious and non-serious) 22 31
Serious adverse events 10 20
Deaths 1 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FGFR2 (MUT) FGFR2 (WT)
Hide Arm/Group Description Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks. Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
All-Cause Mortality
FGFR2 (MUT) FGFR2 (WT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
FGFR2 (MUT) FGFR2 (WT)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/22 (45.45%)   20/31 (64.52%) 
Blood and lymphatic system disorders     
ANAEMIA  1  0/22 (0.00%)  1/31 (3.23%) 
PANCYTOPENIA  1  0/22 (0.00%)  1/31 (3.23%) 
Cardiac disorders     
CARDIAC ARREST  1  0/22 (0.00%)  1/31 (3.23%) 
Congenital, familial and genetic disorders     
GASTROINTESTINAL ARTERIOVENOUS MALFORMATION  1  0/22 (0.00%)  1/31 (3.23%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/22 (0.00%)  2/31 (6.45%) 
ABDOMINAL PAIN UPPER  1  1/22 (4.55%)  0/31 (0.00%) 
COLITIS ISCHAEMIC  1  0/22 (0.00%)  1/31 (3.23%) 
DIARRHOEA  1  1/22 (4.55%)  3/31 (9.68%) 
DYSPHAGIA  1  0/22 (0.00%)  1/31 (3.23%) 
LOWER GASTROINTESTINAL HAEMORRHAGE  1  0/22 (0.00%)  1/31 (3.23%) 
NAUSEA  1  1/22 (4.55%)  2/31 (6.45%) 
PANCREATIC DUCT DILATATION  1  0/22 (0.00%)  1/31 (3.23%) 
SMALL INTESTINAL OBSTRUCTION  1  0/22 (0.00%)  3/31 (9.68%) 
VOMITING  1  2/22 (9.09%)  5/31 (16.13%) 
General disorders     
FATIGUE  1  0/22 (0.00%)  1/31 (3.23%) 
LOCALISED OEDEMA  1  0/22 (0.00%)  1/31 (3.23%) 
MALAISE  1  0/22 (0.00%)  1/31 (3.23%) 
OEDEMA PERIPHERAL  1  0/22 (0.00%)  2/31 (6.45%) 
PYREXIA  1  0/22 (0.00%)  2/31 (6.45%) 
Hepatobiliary disorders     
HEPATITIS TOXIC  1  1/22 (4.55%)  0/31 (0.00%) 
JAUNDICE  1  1/22 (4.55%)  0/31 (0.00%) 
Infections and infestations     
SEPSIS  1  0/22 (0.00%)  1/31 (3.23%) 
URINARY TRACT INFECTION  1  0/22 (0.00%)  2/31 (6.45%) 
UROSEPSIS  1  1/22 (4.55%)  0/31 (0.00%) 
Injury, poisoning and procedural complications     
GASTROENTERITIS RADIATION  1  0/22 (0.00%)  1/31 (3.23%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  0/22 (0.00%)  1/31 (3.23%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/22 (0.00%)  1/31 (3.23%) 
BLOOD BILIRUBIN INCREASED  1  0/22 (0.00%)  1/31 (3.23%) 
PLATELET COUNT DECREASED  1  0/22 (0.00%)  1/31 (3.23%) 
TRANSAMINASES INCREASED  1  0/22 (0.00%)  1/31 (3.23%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  0/22 (0.00%)  1/31 (3.23%) 
DEHYDRATION  1  1/22 (4.55%)  3/31 (9.68%) 
HYPOKALAEMIA  1  0/22 (0.00%)  1/31 (3.23%) 
HYPONATRAEMIA  1  0/22 (0.00%)  1/31 (3.23%) 
HYPOVOLAEMIA  1  1/22 (4.55%)  0/31 (0.00%) 
Musculoskeletal and connective tissue disorders     
GROIN PAIN  1  1/22 (4.55%)  0/31 (0.00%) 
PAIN IN EXTREMITY  1  1/22 (4.55%)  0/31 (0.00%) 
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  1/22 (4.55%)  0/31 (0.00%) 
HEADACHE  1  0/22 (0.00%)  1/31 (3.23%) 
PERIPHERAL SENSORY NEUROPATHY  1  0/22 (0.00%)  1/31 (3.23%) 
SPINAL CORD COMPRESSION  1  0/22 (0.00%)  1/31 (3.23%) 
SYNCOPE  1  0/22 (0.00%)  1/31 (3.23%) 
TRANSIENT ISCHAEMIC ATTACK  1  1/22 (4.55%)  0/31 (0.00%) 
Renal and urinary disorders     
HYDRONEPHROSIS  1  1/22 (4.55%)  0/31 (0.00%) 
RENAL FAILURE  1  0/22 (0.00%)  1/31 (3.23%) 
RENAL FAILURE ACUTE  1  0/22 (0.00%)  2/31 (6.45%) 
URINARY TRACT OBSTRUCTION  1  0/22 (0.00%)  1/31 (3.23%) 
UROGENITAL FISTULA  1  0/22 (0.00%)  1/31 (3.23%) 
Reproductive system and breast disorders     
FEMALE GENITAL TRACT FISTULA  1  0/22 (0.00%)  2/31 (6.45%) 
VAGINAL HAEMORRHAGE  1  1/22 (4.55%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
LUNG INFILTRATION  1  0/22 (0.00%)  1/31 (3.23%) 
PLEURAL EFFUSION  1  0/22 (0.00%)  2/31 (6.45%) 
PNEUMONIA ASPIRATION  1  0/22 (0.00%)  1/31 (3.23%) 
PULMONARY EMBOLISM  1  3/22 (13.64%)  2/31 (6.45%) 
RESPIRATORY FAILURE  1  0/22 (0.00%)  1/31 (3.23%) 
Skin and subcutaneous tissue disorders     
ERYTHEMA MULTIFORME  1  0/22 (0.00%)  1/31 (3.23%) 
Vascular disorders     
DEEP VEIN THROMBOSIS  1  2/22 (9.09%)  0/31 (0.00%) 
EMBOLISM  1  1/22 (4.55%)  2/31 (6.45%) 
HYPERTENSION  1  0/22 (0.00%)  2/31 (6.45%) 
HYPOTENSION  1  0/22 (0.00%)  2/31 (6.45%) 
ORTHOSTATIC HYPOTENSION  1  0/22 (0.00%)  1/31 (3.23%) 
PELVIC VENOUS THROMBOSIS  1  1/22 (4.55%)  0/31 (0.00%) 
PERIPHERAL ISCHAEMIA  1  1/22 (4.55%)  0/31 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FGFR2 (MUT) FGFR2 (WT)
Affected / at Risk (%) Affected / at Risk (%)
Total   21/22 (95.45%)   31/31 (100.00%) 
Blood and lymphatic system disorders     
ANAEMIA  1  3/22 (13.64%)  10/31 (32.26%) 
LEUKOPENIA  1  0/22 (0.00%)  2/31 (6.45%) 
LYMPHOPENIA  1  1/22 (4.55%)  3/31 (9.68%) 
NEUTROPENIA  1  1/22 (4.55%)  2/31 (6.45%) 
THROMBOCYTOPENIA  1  0/22 (0.00%)  4/31 (12.90%) 
Ear and labyrinth disorders     
TINNITUS  1  0/22 (0.00%)  2/31 (6.45%) 
Eye disorders     
DRY EYE  1  2/22 (9.09%)  4/31 (12.90%) 
EYE DISCHARGE  1  0/22 (0.00%)  2/31 (6.45%) 
OCULAR HYPERAEMIA  1  0/22 (0.00%)  3/31 (9.68%) 
VISION BLURRED  1  0/22 (0.00%)  2/31 (6.45%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  5/22 (22.73%)  6/31 (19.35%) 
ABDOMINAL PAIN LOWER  1  1/22 (4.55%)  2/31 (6.45%) 
ABDOMINAL PAIN UPPER  1  0/22 (0.00%)  2/31 (6.45%) 
CONSTIPATION  1  4/22 (18.18%)  6/31 (19.35%) 
DIARRHOEA  1  14/22 (63.64%)  24/31 (77.42%) 
DRY MOUTH  1  3/22 (13.64%)  3/31 (9.68%) 
DYSPEPSIA  1  4/22 (18.18%)  5/31 (16.13%) 
FLATULENCE  1  2/22 (9.09%)  4/31 (12.90%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/22 (4.55%)  2/31 (6.45%) 
NAUSEA  1  16/22 (72.73%)  21/31 (67.74%) 
STOMATITIS  1  1/22 (4.55%)  2/31 (6.45%) 
VOMITING  1  14/22 (63.64%)  21/31 (67.74%) 
General disorders     
ASTHENIA  1  4/22 (18.18%)  5/31 (16.13%) 
FATIGUE  1  9/22 (40.91%)  16/31 (51.61%) 
LOCAL SWELLING  1  2/22 (9.09%)  0/31 (0.00%) 
OEDEMA PERIPHERAL  1  2/22 (9.09%)  4/31 (12.90%) 
PAIN  1  0/22 (0.00%)  6/31 (19.35%) 
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION  1  0/22 (0.00%)  2/31 (6.45%) 
URINARY TRACT INFECTION  1  3/22 (13.64%)  3/31 (9.68%) 
Injury, poisoning and procedural complications     
CONTUSION  1  0/22 (0.00%)  2/31 (6.45%) 
FALL  1  0/22 (0.00%)  2/31 (6.45%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  4/22 (18.18%)  3/31 (9.68%) 
AMYLASE INCREASED  1  0/22 (0.00%)  2/31 (6.45%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  3/22 (13.64%)  2/31 (6.45%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  3/22 (13.64%)  8/31 (25.81%) 
BLOOD BILIRUBIN INCREASED  1  2/22 (9.09%)  0/31 (0.00%) 
BLOOD CHOLESTEROL INCREASED  1  1/22 (4.55%)  3/31 (9.68%) 
BLOOD CREATININE INCREASED  1  3/22 (13.64%)  4/31 (12.90%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  2/22 (9.09%)  2/31 (6.45%) 
LIPASE INCREASED  1  2/22 (9.09%)  2/31 (6.45%) 
LYMPHOCYTE COUNT DECREASED  1  1/22 (4.55%)  2/31 (6.45%) 
PLATELET COUNT DECREASED  1  1/22 (4.55%)  2/31 (6.45%) 
WEIGHT DECREASED  1  7/22 (31.82%)  5/31 (16.13%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  9/22 (40.91%)  9/31 (29.03%) 
DEHYDRATION  1  1/22 (4.55%)  5/31 (16.13%) 
HYPERCHOLESTEROLAEMIA  1  1/22 (4.55%)  4/31 (12.90%) 
HYPERGLYCAEMIA  1  2/22 (9.09%)  5/31 (16.13%) 
HYPERTRIGLYCERIDAEMIA  1  2/22 (9.09%)  9/31 (29.03%) 
HYPOALBUMINAEMIA  1  1/22 (4.55%)  5/31 (16.13%) 
HYPOCALCAEMIA  1  0/22 (0.00%)  4/31 (12.90%) 
HYPOMAGNESAEMIA  1  4/22 (18.18%)  6/31 (19.35%) 
HYPONATRAEMIA  1  1/22 (4.55%)  5/31 (16.13%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  1/22 (4.55%)  2/31 (6.45%) 
BACK PAIN  1  6/22 (27.27%)  2/31 (6.45%) 
BONE PAIN  1  0/22 (0.00%)  2/31 (6.45%) 
MUSCLE SPASMS  1  1/22 (4.55%)  3/31 (9.68%) 
MUSCULAR WEAKNESS  1  0/22 (0.00%)  2/31 (6.45%) 
MUSCULOSKELETAL PAIN  1  0/22 (0.00%)  3/31 (9.68%) 
MYALGIA  1  2/22 (9.09%)  2/31 (6.45%) 
PAIN IN EXTREMITY  1  6/22 (27.27%)  9/31 (29.03%) 
Nervous system disorders     
DIZZINESS  1  3/22 (13.64%)  7/31 (22.58%) 
DYSGEUSIA  1  2/22 (9.09%)  2/31 (6.45%) 
HEADACHE  1  5/22 (22.73%)  6/31 (19.35%) 
PARAESTHESIA  1  2/22 (9.09%)  0/31 (0.00%) 
SOMNOLENCE  1  0/22 (0.00%)  2/31 (6.45%) 
Psychiatric disorders     
ANXIETY  1  0/22 (0.00%)  2/31 (6.45%) 
INSOMNIA  1  2/22 (9.09%)  2/31 (6.45%) 
Renal and urinary disorders     
DYSURIA  1  0/22 (0.00%)  4/31 (12.90%) 
PROTEINURIA  1  1/22 (4.55%)  3/31 (9.68%) 
Reproductive system and breast disorders     
VAGINAL DISCHARGE  1  1/22 (4.55%)  2/31 (6.45%) 
VAGINAL HAEMORRHAGE  1  3/22 (13.64%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  2/22 (9.09%)  6/31 (19.35%) 
DYSPNOEA  1  2/22 (9.09%)  7/31 (22.58%) 
EPISTAXIS  1  0/22 (0.00%)  3/31 (9.68%) 
OROPHARYNGEAL PAIN  1  0/22 (0.00%)  2/31 (6.45%) 
PLEURITIC PAIN  1  0/22 (0.00%)  2/31 (6.45%) 
Skin and subcutaneous tissue disorders     
DERMATITIS ACNEIFORM  1  1/22 (4.55%)  2/31 (6.45%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  2/22 (9.09%)  1/31 (3.23%) 
PRURITUS  1  4/22 (18.18%)  3/31 (9.68%) 
RASH  1  9/22 (40.91%)  11/31 (35.48%) 
RASH MACULO-PAPULAR  1  2/22 (9.09%)  0/31 (0.00%) 
Vascular disorders     
DEEP VEIN THROMBOSIS  1  1/22 (4.55%)  2/31 (6.45%) 
EMBOLISM  1  2/22 (9.09%)  1/31 (3.23%) 
HYPERTENSION  1  4/22 (18.18%)  8/31 (25.81%) 
HYPOTENSION  1  2/22 (9.09%)  2/31 (6.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
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 the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01379534    
Other Study ID Numbers: CTKI258A2211
2011-000266-35 ( EudraCT Number )
First Submitted: June 6, 2011
First Posted: June 23, 2011
Results First Submitted: March 18, 2015
Results First Posted: March 31, 2015
Last Update Posted: May 20, 2015