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Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer (MINT)

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: NCT01151215
Recruitment Status : Terminated (Futility)
First Posted : June 28, 2010
Results First Posted : May 8, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Neoplasms
Breast Neoplasms
Breast Cancer
Interventions Drug: AZD8931
Drug: anastrozole
Drug: Placebo
Enrollment 482
Recruitment Details  
Pre-assignment Details 482 patients were enrolled into the study, of these, 123 patients failed screening and 359 patients were randomized, 120 to AZD8931 40mg(bd) plus anastrozole 1mg (od), 118 to AZD8931 20mg(bd) plus anastrozole 1mg (od) and 121 to placebo(bd) plus anastrozole 1mg(od)
Arm/Group Title AZD8931 40mg + Anastrozole 1mg AZD8931 20mg + Anastrozole 1mg Placebo + Anastrozole 1mg
Hide Arm/Group Description AZD8931 40mg (bd) plus anastrozole 1mg (od) AZD8931 20mg (bd) plus anastrozole 1mg (od) Placebo (bd) plus anastrozole 1mg (od)
Period Title: Overall Study
Started 120 118 121
Completed 100 [1] 95 [1] 102 [1]
Not Completed 20 23 19
Reason Not Completed
Worsening of condition under study             1             1             1
Death             16             20             11
Lost to Follow-up             0             0             3
Withdrawal by Subject             3             1             2
Disease progression             0             1             1
Safety as judged by the investigator             0             0             1
[1]
This is number of patients who were continuing at cut off (ie not withdrawn)
Arm/Group Title AZD8931 40mg + Anastrozole 1mg AZD8931 20mg + Anastrozole 1mg Placebo + Anastrozole 1mg Total
Hide Arm/Group Description AZD8931 40mg (bd) plus anastrozole 1mg (od) AZD8931 20mg (bd) plus anastrozole 1mg (od) Placebo (bd) plus anastrozole 1mg (od) Total of all reporting groups
Overall Number of Baseline Participants 120 118 121 359
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 118 participants 121 participants 359 participants
60.4  (10.69) 62.0  (11.23) 60.5  (10.29) 61.0  (10.73)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 118 participants 121 participants 359 participants
120 118 121 359
[1]
Measure Description: Female only
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 118 participants 121 participants 359 participants
Ethnicity: Hispanic or Latino 51 53 45 149
Ethnicity: Native American 1 0 0 1
Ethnicity: African 2 1 4 7
Ethnicity: Asian (other than Chinese/Japanese) 35 31 32 98
Ethnicity: Chinese 0 0 1 1
Ethnicity: Japanese 0 5 3 8
Ethnicity: Other 12 17 17 46
Ethnicity: Not applicable 19 11 19 49
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 118 participants 121 participants 359 participants
Race: American Indian or Alaska Native 0 0 0 0
Race: Asian 35 37 36 108
Race: Native Hawaiian or Other Pacific Islander 0 0 0 0
Race: Black or African American 5 7 6 18
Race: White 50 56 60 166
Race: Other 30 18 19 67
Study Stratification: Disease Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 118 participants 121 participants 359 participants
Locally advanced 28 27 28 83
Metastatic disease 92 91 93 276
[1]
Measure Description: Study was stratified by locally advanced / metastatic disease
1.Primary Outcome
Title Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Hide Description Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as >=20% increase in the sum of longest diameters of target lesions and an absolute increase of >=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.
Time Frame Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.
Arm/Group Title AZD8931 40mg + Anastrozole 1mg AZD8931 20mg + Anastrozole 1mg Placebo + Anastrozole 1mg
Hide Arm/Group Description:
AZD8931 40mg (bd) plus anastrozole 1mg (od)
AZD8931 20mg (bd) plus anastrozole 1mg (od)
Placebo (bd) plus anastrozole 1mg (od)
Overall Number of Participants Analyzed 120 118 121
Overall Number of Units Analyzed
Type of Units Analyzed: Events
47 49 45
Median (Inter-Quartile Range)
Unit of Measure: Months
13.8
(5.5 to 22.1)
10.9 [1] 
(5.4 to NA)
14.0
(6.7 to 21.8)
[1]
Upper limit of inter-quartile range is not calculable
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD8931 40mg + Anastrozole 1mg, Placebo + Anastrozole 1mg
Comments 345 patients were to be randomised to observe at least 233 progression events, based on HR=0.60, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.485
Comments Statistical significance threshold at this interim analysis was 5%
Method Log Rank
Comments The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.77 to 1.75
Estimation Comments The Hazard Ratio is for AZD8931 40mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio <1 favours AZD8931 40mg + anastrozole 1mg
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD8931 20mg + Anastrozole 1mg, Placebo + Anastrozole 1mg
Comments 345 patients were to be randomised to observe at least 233 progression events, based on HR=0.6, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.135
Comments [Not Specified]
Method Log Rank
Comments The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.91 to 2.06
Estimation Comments The Hazard ratio is for AZD8931 20mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio < 1 favours AZD8931 20mg + anastrozole 1mg
2.Secondary Outcome
Title Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
Hide Description Time from the date of randomization to the date of death (by any cause)
Time Frame Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.
Arm/Group Title AZD8931 40mg + Anastrozole 1mg AZD8931 20mg + Anastrozole 1mg Placebo + Anastrozole 1mg
Hide Arm/Group Description:
AZD8931 40mg (bd) plus anastrozole 1mg (od)
AZD8931 20mg (bd) plus anastrozole 1mg (od)
Placebo (bd) plus anastrozole 1mg (od)
Overall Number of Participants Analyzed 120 118 121
Overall Number of Units Analyzed
Type of Units Analyzed: Events
16 20 12
Median (Inter-Quartile Range)
Unit of Measure: Months
6.9
(4.6 to 14.3)
8.3
(4.7 to 14.0)
7.9
(4.6 to 14.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD8931 20mg AZD8931 40mg Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
AZD8931 20mg AZD8931 40mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AZD8931 20mg AZD8931 40mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/118 (11.86%)      17/120 (14.17%)      11/121 (9.09%)    
Blood and lymphatic system disorders       
ANAEMIA  1  0/118 (0.00%)  0 1/120 (0.83%)  2 0/121 (0.00%)  0
Cardiac disorders       
ANGINA PECTORIS  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
ACUTE MYOCARDIAL INFARCTION  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
COR PULMONALE  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
CARDIAC FAILURE  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
MYOCARDIAL INFARCTION  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
TACHYCARDIA  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
Ear and labyrinth disorders       
VERTIGO  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
Gastrointestinal disorders       
DIARRHOEA  1  1/118 (0.85%)  1 1/120 (0.83%)  1 2/121 (1.65%)  2
GASTRIC HAEMORRHAGE  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
OESOPHAGEAL VARICES HAEMORRHAGE  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
VOMITING  1  1/118 (0.85%)  1 1/120 (0.83%)  1 0/121 (0.00%)  0
General disorders       
DEATH  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
GAIT DISTURBANCE  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
PYREXIA  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
Hepatobiliary disorders       
HYPERBILIRUBINAEMIA  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
Infections and infestations       
HERPES ZOSTER  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
LOWER RESPIRATORY TRACT INFECTION  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
LUNG INFECTION  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
PNEUMONIA  1  2/118 (1.69%)  2 1/120 (0.83%)  1 0/121 (0.00%)  0
SEPSIS  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
URINARY TRACT INFECTION  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
Injury, poisoning and procedural complications       
FALL  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
FEMUR FRACTURE  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
RIB FRACTURE  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
Investigations       
EJECTION FRACTION DECREASED  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
Metabolism and nutrition disorders       
HYPONATRAEMIA  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
HYPERCALCAEMIA  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
HYPERKALAEMIA  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
HYPOVOLAEMIA  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
Musculoskeletal and connective tissue disorders       
BACK PAIN  1  0/118 (0.00%)  0 1/120 (0.83%)  1 1/121 (0.83%)  1
PATHOLOGICAL FRACTURE  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
Nervous system disorders       
CEREBELLAR INFARCTION  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
COMA  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
ISCHAEMIC STROKE  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
MONOPARESIS  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
Renal and urinary disorders       
RENAL FAILURE ACUTE  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
TUBULOINTERSTITIAL NEPHRITIS  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
Reproductive system and breast disorders       
BREAST HAEMORRHAGE  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
ACUTE RESPIRATORY DISTRESS SYNDROME  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
BRONCHOSPASM  1  0/118 (0.00%)  0 0/120 (0.00%)  0 1/121 (0.83%)  1
DYSPNOEA  1  0/118 (0.00%)  0 1/120 (0.83%)  1 1/121 (0.83%)  1
PLEURITIC PAIN  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
PNEUMONIA ASPIRATION  1  1/118 (0.85%)  1 0/120 (0.00%)  0 0/121 (0.00%)  0
Skin and subcutaneous tissue disorders       
DERMATITIS ACNEIFORM  1  0/118 (0.00%)  0 2/120 (1.67%)  2 0/121 (0.00%)  0
RASH  1  0/118 (0.00%)  0 2/120 (1.67%)  2 0/121 (0.00%)  0
Vascular disorders       
HAEMORRHAGE  1  0/118 (0.00%)  0 1/120 (0.83%)  1 0/121 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
AZD8931 20mg AZD8931 40mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   112/118 (94.92%)      115/120 (95.83%)      99/121 (81.82%)    
Blood and lymphatic system disorders       
ANAEMIA  1  7/118 (5.93%)  7 10/120 (8.33%)  10 6/121 (4.96%)  6
LYMPHADENOPATHY  1  1/118 (0.85%)  1 0/120 (0.00%)  0 2/121 (1.65%)  2
NEUTROPENIA  1  3/118 (2.54%)  3 1/120 (0.83%)  1 1/121 (0.83%)  1
LEUKOPENIA  1  2/118 (1.69%)  2 1/120 (0.83%)  1 3/121 (2.48%)  3
Cardiac disorders       
ANGINA PECTORIS  1  0/118 (0.00%)  0 0/120 (0.00%)  0 2/121 (1.65%)  2
PALPITATIONS  1  0/118 (0.00%)  0 4/120 (3.33%)  4 1/121 (0.83%)  1
Ear and labyrinth disorders       
VERTIGO  1  0/118 (0.00%)  0 1/120 (0.83%)  1 2/121 (1.65%)  2
Eye disorders       
BLEPHARITIS  1  2/118 (1.69%)  2 4/120 (3.33%)  7 0/121 (0.00%)  0
DRY EYE  1  5/118 (4.24%)  5 8/120 (6.67%)  8 2/121 (1.65%)  2
EYE PAIN  1  2/118 (1.69%)  2 0/120 (0.00%)  0 2/121 (1.65%)  3
VITREOUS FLOATERS  1  2/118 (1.69%)  2 0/120 (0.00%)  0 0/121 (0.00%)  0
CONJUNCTIVITIS  1  6/118 (5.08%)  7 10/120 (8.33%)  13 2/121 (1.65%)  2
EYE IRRITATION  1  2/118 (1.69%)  2 7/120 (5.83%)  9 1/121 (0.83%)  1
EYE PRURITUS  1  6/118 (5.08%)  7 3/120 (2.50%)  3 4/121 (3.31%)  4
OCULAR HYPERAEMIA  1  1/118 (0.85%)  1 2/120 (1.67%)  2 2/121 (1.65%)  2
VISION BLURRED  1  1/118 (0.85%)  1 4/120 (3.33%)  4 2/121 (1.65%)  2
Gastrointestinal disorders       
ABDOMINAL DISTENSION  1  1/118 (0.85%)  1 0/120 (0.00%)  0 2/121 (1.65%)  2
DYSPEPSIA  1  4/118 (3.39%)  5 11/120 (9.17%)  11 0/121 (0.00%)  0
TOOTHACHE  1  1/118 (0.85%)  1 0/120 (0.00%)  0 2/121 (1.65%)  2
ABDOMINAL PAIN  1  5/118 (4.24%)  5 8/120 (6.67%)  10 9/121 (7.44%)  9
ABDOMINAL PAIN UPPER  1  5/118 (4.24%)  5 6/120 (5.00%)  6 8/121 (6.61%)  8
CONSTIPATION  1  6/118 (5.08%)  6 5/120 (4.17%)  5 7/121 (5.79%)  8
DIARRHOEA  1  46/118 (38.98%)  70 61/120 (50.83%)  103 13/121 (10.74%)  16
DRY MOUTH  1  1/118 (0.85%)  1 2/120 (1.67%)  2 1/121 (0.83%)  1
GASTRITIS  1  3/118 (2.54%)  3 3/120 (2.50%)  3 0/121 (0.00%)  0
MOUTH ULCERATION  1  2/118 (1.69%)  2 4/120 (3.33%)  4 1/121 (0.83%)  1
NAUSEA  1  13/118 (11.02%)  18 16/120 (13.33%)  20 12/121 (9.92%)  14
STOMATITIS  1  6/118 (5.08%)  6 9/120 (7.50%)  9 4/121 (3.31%)  4
TONGUE ULCERATION  1  2/118 (1.69%)  2 0/120 (0.00%)  0 0/121 (0.00%)  0
VOMITING  1  9/118 (7.63%)  10 13/120 (10.83%)  16 11/121 (9.09%)  12
General disorders       
CHEST PAIN  1  3/118 (2.54%)  3 1/120 (0.83%)  1 0/121 (0.00%)  0
MUCOSAL DRYNESS  1  1/118 (0.85%)  1 2/120 (1.67%)  2 0/121 (0.00%)  0
OEDEMA PERIPHERAL  1  10/118 (8.47%)  10 5/120 (4.17%)  6 7/121 (5.79%)  7
PAIN  1  2/118 (1.69%)  2 3/120 (2.50%)  3 2/121 (1.65%)  2
PYREXIA  1  3/118 (2.54%)  4 8/120 (6.67%)  9 5/121 (4.13%)  11
SPINAL PAIN  1  2/118 (1.69%)  2 0/120 (0.00%)  0 1/121 (0.83%)  1
SWELLING  1  2/118 (1.69%)  2 0/120 (0.00%)  0 1/121 (0.83%)  1
XEROSIS  1  0/118 (0.00%)  0 4/120 (3.33%)  4 0/121 (0.00%)  0
ASTHENIA  1  4/118 (3.39%)  5 7/120 (5.83%)  8 9/121 (7.44%)  9
OEDEMA  1  1/118 (0.85%)  1 4/120 (3.33%)  4 0/121 (0.00%)  0
FATIGUE  1  11/118 (9.32%)  11 8/120 (6.67%)  9 11/121 (9.09%)  11
FEELING COLD  1  2/118 (1.69%)  2 0/120 (0.00%)  0 0/121 (0.00%)  0
INFLUENZA LIKE ILLNESS  1  0/118 (0.00%)  0 0/120 (0.00%)  0 2/121 (1.65%)  2
IRRITABILITY  1  0/118 (0.00%)  0 0/120 (0.00%)  0 2/121 (1.65%)  2
MUCOSAL INFLAMMATION  1  6/118 (5.08%)  8 10/120 (8.33%)  13 1/121 (0.83%)  1
NON-CARDIAC CHEST PAIN  1  2/118 (1.69%)  2 2/120 (1.67%)  2 0/121 (0.00%)  0
Immune system disorders       
HYPERSENSITIVITY  1  0/118 (0.00%)  0 2/120 (1.67%)  2 0/121 (0.00%)  0
Infections and infestations       
INFLUENZA  1  1/118 (0.85%)  1 2/120 (1.67%)  2 3/121 (2.48%)  3
PARONYCHIA  1  6/118 (5.08%)  9 22/120 (18.33%)  26 0/121 (0.00%)  0
BREAST INFECTION  1  0/118 (0.00%)  0 0/120 (0.00%)  0 2/121 (1.65%)  2
FUNGAL INFECTION  1  3/118 (2.54%)  3 1/120 (0.83%)  1 1/121 (0.83%)  1
GASTROENTERITIS  1  2/118 (1.69%)  2 1/120 (0.83%)  1 0/121 (0.00%)  0
CELLULITIS  1  3/118 (2.54%)  4 2/120 (1.67%)  2 1/121 (0.83%)  1
CYSTITIS  1  3/118 (2.54%)  3 0/120 (0.00%)  0 0/121 (0.00%)  0
FOLLICULITIS  1  2/118 (1.69%)  2 2/120 (1.67%)  2 0/121 (0.00%)  0
FURUNCLE  1  0/118 (0.00%)  0 2/120 (1.67%)  4 0/121 (0.00%)  0
LOCALISED INFECTION  1  1/118 (0.85%)  1 3/120 (2.50%)  3 0/121 (0.00%)  0
NAIL INFECTION  1  2/118 (1.69%)  2 1/120 (0.83%)  3 0/121 (0.00%)  0
NASOPHARYNGITIS  1  3/118 (2.54%)  4 7/120 (5.83%)  8 2/121 (1.65%)  2
ONYCHOMYCOSIS  1  1/118 (0.85%)  1 3/120 (2.50%)  3 0/121 (0.00%)  0
RASH PUSTULAR  1  7/118 (5.93%)  9 15/120 (12.50%)  17 0/121 (0.00%)  0
SINUSITIS  1  0/118 (0.00%)  0 1/120 (0.83%)  2 3/121 (2.48%)  3
UPPER RESPIRATORY TRACT INFECTION  1  5/118 (4.24%)  5 3/120 (2.50%)  3 2/121 (1.65%)  2
URINARY TRACT INFECTION  1  11/118 (9.32%)  13 13/120 (10.83%)  15 10/121 (8.26%)  15
Injury, poisoning and procedural complications       
CONTUSION  1  0/118 (0.00%)  0 2/120 (1.67%)  2 0/121 (0.00%)  0
PROCEDURAL PAIN  1  0/118 (0.00%)  0 2/120 (1.67%)  2 0/121 (0.00%)  0
Investigations       
EJECTION FRACTION DECREASED  1  2/118 (1.69%)  2 1/120 (0.83%)  1 0/121 (0.00%)  0
WEIGHT INCREASED  1  0/118 (0.00%)  0 2/120 (1.67%)  2 0/121 (0.00%)  0
WEIGHT DECREASED  1  3/118 (2.54%)  3 4/120 (3.33%)  4 0/121 (0.00%)  0
ALANINE AMINOTRANSFERASE INCREASED  1  3/118 (2.54%)  3 5/120 (4.17%)  7 0/121 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED  1  3/118 (2.54%)  5 6/120 (5.00%)  6 0/121 (0.00%)  0
BLOOD ALKALINE PHOSPHATASE INCREASED  1  0/118 (0.00%)  0 3/120 (2.50%)  3 0/121 (0.00%)  0
BLOOD CREATININE INCREASED  1  3/118 (2.54%)  4 0/120 (0.00%)  0 0/121 (0.00%)  0
ELECTROCARDIOGRAM QT PROLONGED  1  2/118 (1.69%)  2 9/120 (7.50%)  10 4/121 (3.31%)  5
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  3/118 (2.54%)  3 5/120 (4.17%)  5 2/121 (1.65%)  2
Metabolism and nutrition disorders       
HYPERGLYCAEMIA  1  3/118 (2.54%)  4 2/120 (1.67%)  2 8/121 (6.61%)  9
HYPOKALAEMIA  1  2/118 (1.69%)  2 3/120 (2.50%)  3 0/121 (0.00%)  0
HYPERCALCAEMIA  1  1/118 (0.85%)  1 0/120 (0.00%)  0 3/121 (2.48%)  3
DECREASED APPETITE  1  14/118 (11.86%)  16 11/120 (9.17%)  11 5/121 (4.13%)  5
DIABETES MELLITUS  1  0/118 (0.00%)  0 1/120 (0.83%)  1 3/121 (2.48%)  3
HYPOALBUMINAEMIA  1  0/118 (0.00%)  0 3/120 (2.50%)  3 0/121 (0.00%)  0
Musculoskeletal and connective tissue disorders       
MUSCLE SPASMS  1  1/118 (0.85%)  1 5/120 (4.17%)  5 4/121 (3.31%)  4
MUSCULOSKELETAL CHEST PAIN  1  2/118 (1.69%)  2 1/120 (0.83%)  1 0/121 (0.00%)  0
BACK PAIN  1  14/118 (11.86%)  15 10/120 (8.33%)  10 12/121 (9.92%)  13
NECK PAIN  1  1/118 (0.85%)  1 1/120 (0.83%)  1 3/121 (2.48%)  3
ARTHRALGIA  1  14/118 (11.86%)  15 10/120 (8.33%)  10 23/121 (19.01%)  27
ARTHRITIS  1  2/118 (1.69%)  2 2/120 (1.67%)  2 2/121 (1.65%)  2
BONE PAIN  1  2/118 (1.69%)  2 6/120 (5.00%)  7 6/121 (4.96%)  6
MUSCULOSKELETAL PAIN  1  6/118 (5.08%)  7 5/120 (4.17%)  5 5/121 (4.13%)  5
MYALGIA  1  0/118 (0.00%)  0 1/120 (0.83%)  1 9/121 (7.44%)  9
PAIN IN EXTREMITY  1  13/118 (11.02%)  15 5/120 (4.17%)  5 7/121 (5.79%)  10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
TUMOUR HAEMORRHAGE  1  2/118 (1.69%)  2 1/120 (0.83%)  2 0/121 (0.00%)  0
Nervous system disorders       
DIZZINESS  1  4/118 (3.39%)  8 11/120 (9.17%)  11 4/121 (3.31%)  4
PERIPHERAL SENSORY NEUROPATHY  1  1/118 (0.85%)  1 1/120 (0.83%)  1 2/121 (1.65%)  2
AGEUSIA  1  1/118 (0.85%)  1 2/120 (1.67%)  2 0/121 (0.00%)  0
DYSGEUSIA  1  3/118 (2.54%)  3 1/120 (0.83%)  1 0/121 (0.00%)  0
HEADACHE  1  10/118 (8.47%)  12 10/120 (8.33%)  13 18/121 (14.88%)  23
LETHARGY  1  2/118 (1.69%)  2 1/120 (0.83%)  1 1/121 (0.83%)  1
NEUROPATHY PERIPHERAL  1  0/118 (0.00%)  0 3/120 (2.50%)  3 0/121 (0.00%)  0
PARAESTHESIA  1  1/118 (0.85%)  1 4/120 (3.33%)  4 0/121 (0.00%)  0
Psychiatric disorders       
DEPRESSION  1  1/118 (0.85%)  1 3/120 (2.50%)  3 1/121 (0.83%)  1
INSOMNIA  1  4/118 (3.39%)  4 4/120 (3.33%)  5 11/121 (9.09%)  12
ANXIETY  1  2/118 (1.69%)  2 1/120 (0.83%)  1 4/121 (3.31%)  5
MOOD SWINGS  1  2/118 (1.69%)  2 0/120 (0.00%)  0 1/121 (0.83%)  1
Renal and urinary disorders       
DYSURIA  1  3/118 (2.54%)  3 5/120 (4.17%)  11 0/121 (0.00%)  0
HAEMATURIA  1  0/118 (0.00%)  0 2/120 (1.67%)  2 0/121 (0.00%)  0
LEUKOCYTURIA  1  1/118 (0.85%)  2 5/120 (4.17%)  6 1/121 (0.83%)  1
PROTEINURIA  1  2/118 (1.69%)  2 0/120 (0.00%)  0 0/121 (0.00%)  0
Reproductive system and breast disorders       
VULVOVAGINAL DRYNESS  1  0/118 (0.00%)  0 2/120 (1.67%)  2 2/121 (1.65%)  2
BREAST PAIN  1  4/118 (3.39%)  4 6/120 (5.00%)  6 6/121 (4.96%)  15
VAGINAL HAEMORRHAGE  1  2/118 (1.69%)  2 1/120 (0.83%)  1 2/121 (1.65%)  2
Respiratory, thoracic and mediastinal disorders       
PRODUCTIVE COUGH  1  0/118 (0.00%)  0 3/120 (2.50%)  3 1/121 (0.83%)  1
COUGH  1  10/118 (8.47%)  10 10/120 (8.33%)  12 6/121 (4.96%)  6
DYSPNOEA  1  4/118 (3.39%)  4 4/120 (3.33%)  4 5/121 (4.13%)  6
NASAL DRYNESS  1  2/118 (1.69%)  2 3/120 (2.50%)  3 0/121 (0.00%)  0
OROPHARYNGEAL PAIN  1  1/118 (0.85%)  1 3/120 (2.50%)  3 2/121 (1.65%)  2
BRONCHOSPASM  1  0/118 (0.00%)  0 1/120 (0.83%)  1 2/121 (1.65%)  2
DYSPHONIA  1  0/118 (0.00%)  0 0/120 (0.00%)  0 2/121 (1.65%)  2
EPISTAXIS  1  2/118 (1.69%)  2 5/120 (4.17%)  6 0/121 (0.00%)  0
NASAL INFLAMMATION  1  1/118 (0.85%)  1 2/120 (1.67%)  2 0/121 (0.00%)  0
RHINORRHOEA  1  0/118 (0.00%)  0 1/120 (0.83%)  1 3/121 (2.48%)  3
Skin and subcutaneous tissue disorders       
BLISTER  1  2/118 (1.69%)  3 1/120 (0.83%)  1 0/121 (0.00%)  0
NAIL DISORDER  1  1/118 (0.85%)  1 2/120 (1.67%)  2 0/121 (0.00%)  0
ALOPECIA  1  6/118 (5.08%)  6 9/120 (7.50%)  9 5/121 (4.13%)  5
DRY SKIN  1  22/118 (18.64%)  24 30/120 (25.00%)  32 3/121 (2.48%)  3
HYPERHIDROSIS  1  1/118 (0.85%)  1 0/120 (0.00%)  0 2/121 (1.65%)  2
NAIL RIDGING  1  1/118 (0.85%)  1 2/120 (1.67%)  2 0/121 (0.00%)  0
ONYCHOMADESIS  1  0/118 (0.00%)  0 2/120 (1.67%)  2 0/121 (0.00%)  0
PAPULE  1  2/118 (1.69%)  2 1/120 (0.83%)  1 0/121 (0.00%)  0
RASH ERYTHEMATOUS  1  1/118 (0.85%)  1 2/120 (1.67%)  2 0/121 (0.00%)  0
SKIN EXFOLIATION  1  0/118 (0.00%)  0 5/120 (4.17%)  5 1/121 (0.83%)  1
URTICARIA  1  2/118 (1.69%)  2 0/120 (0.00%)  0 2/121 (1.65%)  2
ACNE  1  2/118 (1.69%)  2 6/120 (5.00%)  9 1/121 (0.83%)  1
DERMATITIS  1  2/118 (1.69%)  2 6/120 (5.00%)  6 0/121 (0.00%)  0
DERMATITIS ACNEIFORM  1  19/118 (16.10%)  23 31/120 (25.83%)  37 2/121 (1.65%)  2
ERYTHEMA  1  4/118 (3.39%)  4 7/120 (5.83%)  9 3/121 (2.48%)  15
NAIL DYSTROPHY  1  0/118 (0.00%)  0 2/120 (1.67%)  2 0/121 (0.00%)  0
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  3/118 (2.54%)  3 13/120 (10.83%)  13 1/121 (0.83%)  1
PRURITUS  1  15/118 (12.71%)  17 10/120 (8.33%)  13 4/121 (3.31%)  4
RASH  1  38/118 (32.20%)  42 56/120 (46.67%)  78 15/121 (12.40%)  20
RASH MACULO-PAPULAR  1  7/118 (5.93%)  7 6/120 (5.00%)  7 2/121 (1.65%)  2
RASH PAPULAR  1  2/118 (1.69%)  2 1/120 (0.83%)  1 1/121 (0.83%)  1
SKIN ULCER  1  2/118 (1.69%)  2 2/120 (1.67%)  3 1/121 (0.83%)  1
Vascular disorders       
LYMPHOEDEMA  1  1/118 (0.85%)  1 1/120 (0.83%)  1 2/121 (1.65%)  2
HOT FLUSH  1  4/118 (3.39%)  4 1/120 (0.83%)  1 11/121 (9.09%)  11
HYPERTENSION  1  7/118 (5.93%)  8 9/120 (7.50%)  10 3/121 (2.48%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15
The final analysis for this study is the analysis that was sent to the study's IDMC, based on a data cut-off of 31 August 2012. At the data cut-off point the data was cleaned, but 9 adverse events were not coded. These events are not included here.
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.
Results Point of Contact
Name/Title: Dr Serban Ghiorghiu
Organization: Astrazeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01151215     History of Changes
Other Study ID Numbers: D0102C00004
First Submitted: June 15, 2010
First Posted: June 28, 2010
Results First Submitted: January 29, 2014
Results First Posted: May 8, 2014
Last Update Posted: July 25, 2014