Trial Outcomes & Findings for Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer (NCT NCT01151215)
NCT ID: NCT01151215
Last Updated: 2014-07-25
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
482 participants
Primary outcome timeframe
Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012
Results posted on
2014-07-25
Participant Flow
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)
Participant milestones
| Measure |
AZD8931 40mg + Anastrozole 1mg
AZD8931 40mg (bd) plus anastrozole 1mg (od)
|
AZD8931 20mg + Anastrozole 1mg
AZD8931 20mg (bd) plus anastrozole 1mg (od)
|
Placebo + Anastrozole 1mg
Placebo (bd) plus anastrozole 1mg (od)
|
|---|---|---|---|
|
Overall Study
STARTED
|
120
|
118
|
121
|
|
Overall Study
COMPLETED
|
100
|
95
|
102
|
|
Overall Study
NOT COMPLETED
|
20
|
23
|
19
|
Reasons for withdrawal
| Measure |
AZD8931 40mg + Anastrozole 1mg
AZD8931 40mg (bd) plus anastrozole 1mg (od)
|
AZD8931 20mg + Anastrozole 1mg
AZD8931 20mg (bd) plus anastrozole 1mg (od)
|
Placebo + Anastrozole 1mg
Placebo (bd) plus anastrozole 1mg (od)
|
|---|---|---|---|
|
Overall Study
Worsening of condition under study
|
1
|
1
|
1
|
|
Overall Study
Death
|
16
|
20
|
11
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
2
|
|
Overall Study
Disease progression
|
0
|
1
|
1
|
|
Overall Study
Safety as judged by the investigator
|
0
|
0
|
1
|
Baseline Characteristics
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
Baseline characteristics by cohort
| Measure |
AZD8931 40mg + Anastrozole 1mg
n=120 Participants
AZD8931 40mg (bd) plus anastrozole 1mg (od)
|
AZD8931 20mg + Anastrozole 1mg
n=118 Participants
AZD8931 20mg (bd) plus anastrozole 1mg (od)
|
Placebo + Anastrozole 1mg
n=121 Participants
Placebo (bd) plus anastrozole 1mg (od)
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.4 Years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
62.0 Years
STANDARD_DEVIATION 11.23 • n=7 Participants
|
60.5 Years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
61.0 Years
STANDARD_DEVIATION 10.73 • n=4 Participants
|
|
Sex/Gender, Customized
|
120 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
359 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Native American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: African
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Asian (other than Chinese/Japanese)
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Chinese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Japanese
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Other
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Not applicable
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: Asian
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: White
|
50 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: Other
|
30 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Study Stratification: Disease Classification
Locally advanced
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Study Stratification: Disease Classification
Metastatic disease
|
92 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012Population: Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.
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.
Outcome measures
| Measure |
AZD8931 40mg + Anastrozole 1mg
n=47 Events
AZD8931 40mg (bd) plus anastrozole 1mg (od)
|
AZD8931 20mg + Anastrozole 1mg
n=49 Events
AZD8931 20mg (bd) plus anastrozole 1mg (od)
|
Placebo + Anastrozole 1mg
n=45 Events
Placebo (bd) plus anastrozole 1mg (od)
|
|---|---|---|---|
|
Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
|
13.8 Months
Interval 5.5 to 22.1
|
10.9 Months
Interval 5.4 to
Upper limit of inter-quartile range is not calculable
|
14.0 Months
Interval 6.7 to 21.8
|
SECONDARY outcome
Timeframe: Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival statusPopulation: Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.
Time from the date of randomization to the date of death (by any cause)
Outcome measures
| Measure |
AZD8931 40mg + Anastrozole 1mg
n=16 Events
AZD8931 40mg (bd) plus anastrozole 1mg (od)
|
AZD8931 20mg + Anastrozole 1mg
n=20 Events
AZD8931 20mg (bd) plus anastrozole 1mg (od)
|
Placebo + Anastrozole 1mg
n=12 Events
Placebo (bd) plus anastrozole 1mg (od)
|
|---|---|---|---|
|
Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
|
6.9 Months
Interval 4.6 to 14.3
|
8.3 Months
Interval 4.7 to 14.0
|
7.9 Months
Interval 4.6 to 14.5
|
Adverse Events
AZD8931 20mg
Serious events: 14 serious events
Other events: 112 other events
Deaths: 0 deaths
AZD8931 40mg
Serious events: 17 serious events
Other events: 115 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD8931 20mg
n=118 participants at risk
|
AZD8931 40mg
n=120 participants at risk
|
Placebo
n=121 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.85%
1/118 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.85%
1/118 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
General disorders
GAIT DISTURBANCE
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
General disorders
DEATH
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/118
|
0.83%
1/120 • Number of events 2
|
0.00%
0/121
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Cardiac disorders
COR PULMONALE
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Ear and labyrinth disorders
VERTIGO
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
General disorders
PYREXIA
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Infections and infestations
SEPSIS
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Injury, poisoning and procedural complications
FALL
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Investigations
EJECTION FRACTION DECREASED
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.83%
1/121 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Nervous system disorders
COMA
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Nervous system disorders
MONOPARESIS
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Renal and urinary disorders
TUBULOINTERSTITIAL NEPHRITIS
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Reproductive system and breast disorders
BREAST HAEMORRHAGE
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/118
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.83%
1/121 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
0.00%
0/121
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
Other adverse events
| Measure |
AZD8931 20mg
n=118 participants at risk
|
AZD8931 40mg
n=120 participants at risk
|
Placebo
n=121 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.9%
7/118 • Number of events 7
|
8.3%
10/120 • Number of events 10
|
5.0%
6/121 • Number of events 6
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.5%
3/118 • Number of events 3
|
0.83%
1/120 • Number of events 1
|
0.83%
1/121 • Number of events 1
|
|
General disorders
CHEST PAIN
|
2.5%
3/118 • Number of events 3
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
General disorders
MUCOSAL DRYNESS
|
0.85%
1/118 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
General disorders
OEDEMA PERIPHERAL
|
8.5%
10/118 • Number of events 10
|
4.2%
5/120 • Number of events 6
|
5.8%
7/121 • Number of events 7
|
|
General disorders
PAIN
|
1.7%
2/118 • Number of events 2
|
2.5%
3/120 • Number of events 3
|
1.7%
2/121 • Number of events 2
|
|
General disorders
PYREXIA
|
2.5%
3/118 • Number of events 4
|
6.7%
8/120 • Number of events 9
|
4.1%
5/121 • Number of events 11
|
|
General disorders
SPINAL PAIN
|
1.7%
2/118 • Number of events 2
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
General disorders
SWELLING
|
1.7%
2/118 • Number of events 2
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
General disorders
XEROSIS
|
0.00%
0/118
|
3.3%
4/120 • Number of events 4
|
0.00%
0/121
|
|
Infections and infestations
INFLUENZA
|
0.85%
1/118 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
2.5%
3/121 • Number of events 3
|
|
Infections and infestations
PARONYCHIA
|
5.1%
6/118 • Number of events 9
|
18.3%
22/120 • Number of events 26
|
0.00%
0/121
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Investigations
EJECTION FRACTION DECREASED
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
2.5%
3/118 • Number of events 4
|
1.7%
2/120 • Number of events 2
|
6.6%
8/121 • Number of events 9
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
1.7%
2/118 • Number of events 2
|
2.5%
3/120 • Number of events 3
|
0.00%
0/121
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.85%
1/118 • Number of events 1
|
4.2%
5/120 • Number of events 5
|
3.3%
4/121 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Nervous system disorders
DIZZINESS
|
3.4%
4/118 • Number of events 8
|
9.2%
11/120 • Number of events 11
|
3.3%
4/121 • Number of events 4
|
|
Psychiatric disorders
DEPRESSION
|
0.85%
1/118 • Number of events 1
|
2.5%
3/120 • Number of events 3
|
0.83%
1/121 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/118
|
2.5%
3/120 • Number of events 3
|
0.83%
1/121 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
1.7%
2/118 • Number of events 3
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
0.85%
1/118 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
2.5%
3/121 • Number of events 3
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/118
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
Eye disorders
BLEPHARITIS
|
1.7%
2/118 • Number of events 2
|
3.3%
4/120 • Number of events 7
|
0.00%
0/121
|
|
Eye disorders
DRY EYE
|
4.2%
5/118 • Number of events 5
|
6.7%
8/120 • Number of events 8
|
1.7%
2/121 • Number of events 2
|
|
Eye disorders
EYE PAIN
|
1.7%
2/118 • Number of events 2
|
0.00%
0/120
|
1.7%
2/121 • Number of events 3
|
|
Eye disorders
VITREOUS FLOATERS
|
1.7%
2/118 • Number of events 2
|
0.00%
0/120
|
0.00%
0/121
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
Gastrointestinal disorders
DYSPEPSIA
|
3.4%
4/118 • Number of events 5
|
9.2%
11/120 • Number of events 11
|
0.00%
0/121
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
General disorders
ASTHENIA
|
3.4%
4/118 • Number of events 5
|
5.8%
7/120 • Number of events 8
|
7.4%
9/121 • Number of events 9
|
|
General disorders
OEDEMA
|
0.85%
1/118 • Number of events 1
|
3.3%
4/120 • Number of events 4
|
0.00%
0/121
|
|
Infections and infestations
BREAST INFECTION
|
0.00%
0/118
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
Infections and infestations
FUNGAL INFECTION
|
2.5%
3/118 • Number of events 3
|
0.83%
1/120 • Number of events 1
|
0.83%
1/121 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Investigations
WEIGHT DECREASED
|
2.5%
3/118 • Number of events 3
|
3.3%
4/120 • Number of events 4
|
0.00%
0/121
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
2.5%
3/121 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.9%
14/118 • Number of events 15
|
8.3%
10/120 • Number of events 10
|
9.9%
12/121 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.85%
1/118 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
2.5%
3/121 • Number of events 3
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.85%
1/118 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
|
Psychiatric disorders
INSOMNIA
|
3.4%
4/118 • Number of events 4
|
3.3%
4/120 • Number of events 5
|
9.1%
11/121 • Number of events 12
|
|
Renal and urinary disorders
DYSURIA
|
2.5%
3/118 • Number of events 3
|
4.2%
5/120 • Number of events 11
|
0.00%
0/121
|
|
Reproductive system and breast disorders
VULVOVAGINAL DRYNESS
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
1.7%
2/121 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.5%
10/118 • Number of events 10
|
8.3%
10/120 • Number of events 12
|
5.0%
6/121 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.4%
4/118 • Number of events 4
|
3.3%
4/120 • Number of events 4
|
4.1%
5/121 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
1.7%
2/118 • Number of events 2
|
2.5%
3/120 • Number of events 3
|
0.00%
0/121
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.85%
1/118 • Number of events 1
|
2.5%
3/120 • Number of events 3
|
1.7%
2/121 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
5.1%
6/118 • Number of events 6
|
7.5%
9/120 • Number of events 9
|
4.1%
5/121 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
18.6%
22/118 • Number of events 24
|
25.0%
30/120 • Number of events 32
|
2.5%
3/121 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.85%
1/118 • Number of events 1
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
NAIL RIDGING
|
0.85%
1/118 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Skin and subcutaneous tissue disorders
ONYCHOMADESIS
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Skin and subcutaneous tissue disorders
PAPULE
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.85%
1/118 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/118
|
4.2%
5/120 • Number of events 5
|
0.83%
1/121 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
1.7%
2/118 • Number of events 2
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
Vascular disorders
LYMPHOEDEMA
|
0.85%
1/118 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/118
|
3.3%
4/120 • Number of events 4
|
0.83%
1/121 • Number of events 1
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
|
Eye disorders
CONJUNCTIVITIS
|
5.1%
6/118 • Number of events 7
|
8.3%
10/120 • Number of events 13
|
1.7%
2/121 • Number of events 2
|
|
Eye disorders
EYE IRRITATION
|
1.7%
2/118 • Number of events 2
|
5.8%
7/120 • Number of events 9
|
0.83%
1/121 • Number of events 1
|
|
Eye disorders
EYE PRURITUS
|
5.1%
6/118 • Number of events 7
|
2.5%
3/120 • Number of events 3
|
3.3%
4/121 • Number of events 4
|
|
Eye disorders
OCULAR HYPERAEMIA
|
0.85%
1/118 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
1.7%
2/121 • Number of events 2
|
|
Eye disorders
VISION BLURRED
|
0.85%
1/118 • Number of events 1
|
3.3%
4/120 • Number of events 4
|
1.7%
2/121 • Number of events 2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.2%
5/118 • Number of events 5
|
6.7%
8/120 • Number of events 10
|
7.4%
9/121 • Number of events 9
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.2%
5/118 • Number of events 5
|
5.0%
6/120 • Number of events 6
|
6.6%
8/121 • Number of events 8
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.1%
6/118 • Number of events 6
|
4.2%
5/120 • Number of events 5
|
5.8%
7/121 • Number of events 8
|
|
Gastrointestinal disorders
DIARRHOEA
|
39.0%
46/118 • Number of events 70
|
50.8%
61/120 • Number of events 103
|
10.7%
13/121 • Number of events 16
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.85%
1/118 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
0.83%
1/121 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS
|
2.5%
3/118 • Number of events 3
|
2.5%
3/120 • Number of events 3
|
0.00%
0/121
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
1.7%
2/118 • Number of events 2
|
3.3%
4/120 • Number of events 4
|
0.83%
1/121 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
11.0%
13/118 • Number of events 18
|
13.3%
16/120 • Number of events 20
|
9.9%
12/121 • Number of events 14
|
|
Gastrointestinal disorders
STOMATITIS
|
5.1%
6/118 • Number of events 6
|
7.5%
9/120 • Number of events 9
|
3.3%
4/121 • Number of events 4
|
|
Gastrointestinal disorders
TONGUE ULCERATION
|
1.7%
2/118 • Number of events 2
|
0.00%
0/120
|
0.00%
0/121
|
|
Gastrointestinal disorders
VOMITING
|
7.6%
9/118 • Number of events 10
|
10.8%
13/120 • Number of events 16
|
9.1%
11/121 • Number of events 12
|
|
General disorders
FATIGUE
|
9.3%
11/118 • Number of events 11
|
6.7%
8/120 • Number of events 9
|
9.1%
11/121 • Number of events 11
|
|
General disorders
FEELING COLD
|
1.7%
2/118 • Number of events 2
|
0.00%
0/120
|
0.00%
0/121
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/118
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
General disorders
IRRITABILITY
|
0.00%
0/118
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
General disorders
MUCOSAL INFLAMMATION
|
5.1%
6/118 • Number of events 8
|
8.3%
10/120 • Number of events 13
|
0.83%
1/121 • Number of events 1
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.7%
2/118 • Number of events 2
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Infections and infestations
CELLULITIS
|
2.5%
3/118 • Number of events 4
|
1.7%
2/120 • Number of events 2
|
0.83%
1/121 • Number of events 1
|
|
Infections and infestations
CYSTITIS
|
2.5%
3/118 • Number of events 3
|
0.00%
0/120
|
0.00%
0/121
|
|
Infections and infestations
FOLLICULITIS
|
1.7%
2/118 • Number of events 2
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/118
|
1.7%
2/120 • Number of events 4
|
0.00%
0/121
|
|
Infections and infestations
LOCALISED INFECTION
|
0.85%
1/118 • Number of events 1
|
2.5%
3/120 • Number of events 3
|
0.00%
0/121
|
|
Infections and infestations
NAIL INFECTION
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 3
|
0.00%
0/121
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.5%
3/118 • Number of events 4
|
5.8%
7/120 • Number of events 8
|
1.7%
2/121 • Number of events 2
|
|
Infections and infestations
ONYCHOMYCOSIS
|
0.85%
1/118 • Number of events 1
|
2.5%
3/120 • Number of events 3
|
0.00%
0/121
|
|
Infections and infestations
RASH PUSTULAR
|
5.9%
7/118 • Number of events 9
|
12.5%
15/120 • Number of events 17
|
0.00%
0/121
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/118
|
0.83%
1/120 • Number of events 2
|
2.5%
3/121 • Number of events 3
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.2%
5/118 • Number of events 5
|
2.5%
3/120 • Number of events 3
|
1.7%
2/121 • Number of events 2
|
|
Infections and infestations
URINARY TRACT INFECTION
|
9.3%
11/118 • Number of events 13
|
10.8%
13/120 • Number of events 15
|
8.3%
10/121 • Number of events 15
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.5%
3/118 • Number of events 3
|
4.2%
5/120 • Number of events 7
|
0.00%
0/121
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.5%
3/118 • Number of events 5
|
5.0%
6/120 • Number of events 6
|
0.00%
0/121
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/118
|
2.5%
3/120 • Number of events 3
|
0.00%
0/121
|
|
Investigations
BLOOD CREATININE INCREASED
|
2.5%
3/118 • Number of events 4
|
0.00%
0/120
|
0.00%
0/121
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
1.7%
2/118 • Number of events 2
|
7.5%
9/120 • Number of events 10
|
3.3%
4/121 • Number of events 5
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
2.5%
3/118 • Number of events 3
|
4.2%
5/120 • Number of events 5
|
1.7%
2/121 • Number of events 2
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
11.9%
14/118 • Number of events 16
|
9.2%
11/120 • Number of events 11
|
4.1%
5/121 • Number of events 5
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
2.5%
3/121 • Number of events 3
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/118
|
2.5%
3/120 • Number of events 3
|
0.00%
0/121
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.9%
14/118 • Number of events 15
|
8.3%
10/120 • Number of events 10
|
19.0%
23/121 • Number of events 27
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.7%
2/118 • Number of events 2
|
1.7%
2/120 • Number of events 2
|
1.7%
2/121 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.7%
2/118 • Number of events 2
|
5.0%
6/120 • Number of events 7
|
5.0%
6/121 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.1%
6/118 • Number of events 7
|
4.2%
5/120 • Number of events 5
|
4.1%
5/121 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
7.4%
9/121 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
11.0%
13/118 • Number of events 15
|
4.2%
5/120 • Number of events 5
|
5.8%
7/121 • Number of events 10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 2
|
0.00%
0/121
|
|
Nervous system disorders
AGEUSIA
|
0.85%
1/118 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Nervous system disorders
DYSGEUSIA
|
2.5%
3/118 • Number of events 3
|
0.83%
1/120 • Number of events 1
|
0.00%
0/121
|
|
Nervous system disorders
HEADACHE
|
8.5%
10/118 • Number of events 12
|
8.3%
10/120 • Number of events 13
|
14.9%
18/121 • Number of events 23
|
|
Nervous system disorders
LETHARGY
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
0.83%
1/121 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/118
|
2.5%
3/120 • Number of events 3
|
0.00%
0/121
|
|
Nervous system disorders
PARAESTHESIA
|
0.85%
1/118 • Number of events 1
|
3.3%
4/120 • Number of events 4
|
0.00%
0/121
|
|
Psychiatric disorders
ANXIETY
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
3.3%
4/121 • Number of events 5
|
|
Psychiatric disorders
MOOD SWINGS
|
1.7%
2/118 • Number of events 2
|
0.00%
0/120
|
0.83%
1/121 • Number of events 1
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Renal and urinary disorders
LEUKOCYTURIA
|
0.85%
1/118 • Number of events 2
|
4.2%
5/120 • Number of events 6
|
0.83%
1/121 • Number of events 1
|
|
Renal and urinary disorders
PROTEINURIA
|
1.7%
2/118 • Number of events 2
|
0.00%
0/120
|
0.00%
0/121
|
|
Reproductive system and breast disorders
BREAST PAIN
|
3.4%
4/118 • Number of events 4
|
5.0%
6/120 • Number of events 6
|
5.0%
6/121 • Number of events 15
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/118
|
0.00%
0/120
|
1.7%
2/121 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.7%
2/118 • Number of events 2
|
4.2%
5/120 • Number of events 6
|
0.00%
0/121
|
|
Respiratory, thoracic and mediastinal disorders
NASAL INFLAMMATION
|
0.85%
1/118 • Number of events 1
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/118
|
0.83%
1/120 • Number of events 1
|
2.5%
3/121 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
ACNE
|
1.7%
2/118 • Number of events 2
|
5.0%
6/120 • Number of events 9
|
0.83%
1/121 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
1.7%
2/118 • Number of events 2
|
5.0%
6/120 • Number of events 6
|
0.00%
0/121
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
16.1%
19/118 • Number of events 23
|
25.8%
31/120 • Number of events 37
|
1.7%
2/121 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
3.4%
4/118 • Number of events 4
|
5.8%
7/120 • Number of events 9
|
2.5%
3/121 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
NAIL DYSTROPHY
|
0.00%
0/118
|
1.7%
2/120 • Number of events 2
|
0.00%
0/121
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
2.5%
3/118 • Number of events 3
|
10.8%
13/120 • Number of events 13
|
0.83%
1/121 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.7%
15/118 • Number of events 17
|
8.3%
10/120 • Number of events 13
|
3.3%
4/121 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
RASH
|
32.2%
38/118 • Number of events 42
|
46.7%
56/120 • Number of events 78
|
12.4%
15/121 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
5.9%
7/118 • Number of events 7
|
5.0%
6/120 • Number of events 7
|
1.7%
2/121 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
1.7%
2/118 • Number of events 2
|
0.83%
1/120 • Number of events 1
|
0.83%
1/121 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
1.7%
2/118 • Number of events 2
|
1.7%
2/120 • Number of events 3
|
0.83%
1/121 • Number of events 1
|
|
Vascular disorders
HOT FLUSH
|
3.4%
4/118 • Number of events 4
|
0.83%
1/120 • Number of events 1
|
9.1%
11/121 • Number of events 11
|
|
Vascular disorders
HYPERTENSION
|
5.9%
7/118 • Number of events 8
|
7.5%
9/120 • Number of events 10
|
2.5%
3/121 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60