Trial Outcomes & Findings for AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer (NCT NCT00610714)
NCT ID: NCT00610714
Last Updated: 2012-12-18
Results Overview
Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
211 participants
Primary outcome timeframe
Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)
Results posted on
2012-12-18
Participant Flow
Patients were recruited at 58 cancer clinics in 12 countries (Bulgaria, Canada, Denmark, France, Netherlands, Norway, Peru, Portugal, Romania, Russia, Spain and UK) between April 2008 and March 2009.
Following enrolment there was a 28 day screening period, after which if all inclusion/exclusion criteria were met, patients were randomized to treatment.
Participant milestones
| Measure |
AZD0530 , Paclitaxel , Carboplatin i.v.
AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
|
Carboplatin ,Paclitaxel
Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
106
|
|
Overall Study
COMPLETED
|
79
|
82
|
|
Overall Study
NOT COMPLETED
|
26
|
24
|
Reasons for withdrawal
| Measure |
AZD0530 , Paclitaxel , Carboplatin i.v.
AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
|
Carboplatin ,Paclitaxel
Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Death
|
12
|
18
|
|
Overall Study
Withdrawal by Subject
|
9
|
3
|
|
Overall Study
Study completion at 120 PFS events
|
2
|
2
|
Baseline Characteristics
AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
Baseline characteristics by cohort
| Measure |
AZD0530 , Paclitaxel , Carboplatin i.v.
n=105 Participants
AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
|
Carboplatin ,Paclitaxel
n=106 Participants
Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.4 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
58.265 Years
STANDARD_DEVIATION 10.077 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
105 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
94 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Body Surface Area (BSA)
|
1.758 m^2
STANDARD_DEVIATION 0.17 • n=5 Participants
|
1.766 m^2
STANDARD_DEVIATION 0.206 • n=7 Participants
|
1.762 m^2
STANDARD_DEVIATION 0.189 • n=5 Participants
|
|
World Health Organization (WHO) Performance Status
0
|
60 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
World Health Organization (WHO) Performance Status
1
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
World Health Organization (WHO) Performance Status
2
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
World Health Organization (WHO) Performance Status
3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
World Health Organization (WHO) Performance Status
4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Primary Tumour Location (Number of Participants)
Ovary
|
98 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Primary Tumour Location (Number of Participants)
Peritoneum
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Primary Tumour Location (Number of Participants)
Uterine/fallopian tube
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Primary Tumour Location (Number of Participants)
Site cannot be determined
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary Tumour Location (Number of Participants)
Unavailable
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Tumour Grade
Well Differentiated (G1)
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Tumour Grade
Mod. Differentiated (G2)
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Tumour Grade
Unavailable (G3)
|
45 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Tumour Grade
Undifferentiated (G4)
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Tumour Grade
Unassessable (GX)
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Tumour Grade
Missing
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.
Outcome measures
| Measure |
AZD0530 , Paclitaxel , Carboplatin i.v.
n=88 Participants
AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
|
Carboplatin ,Paclitaxel
n=87 Participants
Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
|
|---|---|---|
|
Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)
|
47 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.
Outcome measures
| Measure |
AZD0530 , Paclitaxel , Carboplatin i.v.
n=96 Participants
AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
|
Carboplatin ,Paclitaxel
n=93 Participants
Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
|
|---|---|---|
|
Progression-free Survival (PFS) as Evaluated by RECIST
|
8.28 Months
Interval 0.0 to 11.04
|
7.79 Months
Interval 0.72 to 12.12
|
SECONDARY outcome
Timeframe: Date of randomization to death due to any causeInterval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead
Outcome measures
| Measure |
AZD0530 , Paclitaxel , Carboplatin i.v.
n=96 Participants
AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
|
Carboplatin ,Paclitaxel
n=93 Participants
Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
|
|---|---|---|
|
Overall Survival (Number of Deaths)
|
12 Participants
|
14 Participants
|
Adverse Events
AZD0530 , Paclitaxel , Carboplatin i.v.
Serious events: 46 serious events
Other events: 102 other events
Deaths: 0 deaths
Carboplatin ,Paclitaxel
Serious events: 26 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD0530 , Paclitaxel , Carboplatin i.v.
n=105 participants at risk
AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
|
Carboplatin ,Paclitaxel
n=106 participants at risk
Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
|
|---|---|---|
|
Injury, poisoning and procedural complications
Blood Creatinine Increased
|
0.95%
1/105
|
0.00%
0/106
|
|
Injury, poisoning and procedural complications
Haemoglobin Decreased
|
0.00%
0/105
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/105
|
1.9%
2/106
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.95%
1/105
|
0.00%
0/106
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.95%
1/105
|
0.00%
0/106
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.95%
1/105
|
0.00%
0/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic Syndrome
|
0.95%
1/105
|
0.00%
0/106
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/105
|
0.94%
1/106
|
|
Nervous system disorders
Presyncope
|
0.00%
0/105
|
0.94%
1/106
|
|
Nervous system disorders
Somnolence
|
0.00%
0/105
|
0.94%
1/106
|
|
Renal and urinary disorders
Renal Colic
|
0.95%
1/105
|
0.00%
0/106
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.95%
1/105
|
0.00%
0/106
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.00%
0/105
|
0.94%
1/106
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.95%
1/105
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.95%
1/105
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.95%
1/105
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.95%
1/105
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.95%
1/105
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.95%
1/105
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.95%
1/105
|
0.94%
1/106
|
|
Vascular disorders
Hot Flush
|
0.00%
0/105
|
0.94%
1/106
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
13.3%
14/105
|
1.9%
2/106
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
3/105
|
0.00%
0/106
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
3/105
|
0.00%
0/106
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.95%
1/105
|
1.9%
2/106
|
|
Blood and lymphatic system disorders
Febrile Bone Marrow Aplasia
|
0.95%
1/105
|
0.94%
1/106
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/105
|
0.94%
1/106
|
|
Cardiac disorders
Atrial Fibrillation
|
1.9%
2/105
|
0.00%
0/106
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/105
|
0.94%
1/106
|
|
Gastrointestinal disorders
Ileus
|
2.9%
3/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
3/105
|
0.94%
1/106
|
|
Gastrointestinal disorders
Ascites
|
0.95%
1/105
|
1.9%
2/106
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.9%
2/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/105
|
0.94%
1/106
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.95%
1/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Constipation
|
0.95%
1/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Diarrhoea
|
0.95%
1/105
|
0.94%
1/106
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.95%
1/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.95%
1/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Intestinal Fistula
|
0.95%
1/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.95%
1/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Nausea
|
0.95%
1/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/105
|
0.94%
1/106
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/105
|
0.94%
1/106
|
|
General disorders
Pyrexia
|
3.8%
4/105
|
0.94%
1/106
|
|
General disorders
Asthenia
|
1.9%
2/105
|
0.00%
0/106
|
|
Immune system disorders
Drug Hypersensitivity
|
3.8%
4/105
|
4.7%
5/106
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/105
|
0.94%
1/106
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/105
|
0.94%
1/106
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.95%
1/105
|
0.00%
0/106
|
|
Infections and infestations
Cellulitis
|
0.95%
1/105
|
0.00%
0/106
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/105
|
0.94%
1/106
|
|
Infections and infestations
Device Related Sepsis
|
0.95%
1/105
|
0.00%
0/106
|
|
Infections and infestations
Enteritis Infectious
|
0.95%
1/105
|
0.00%
0/106
|
|
Infections and infestations
Escherichia Infection
|
0.95%
1/105
|
0.00%
0/106
|
|
Infections and infestations
Neutropenic Infection
|
0.95%
1/105
|
0.00%
0/106
|
|
Infections and infestations
Septic Shock
|
0.00%
0/105
|
0.94%
1/106
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/105
|
0.94%
1/106
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/105
|
0.94%
1/106
|
|
Infections and infestations
Urosepsis
|
0.95%
1/105
|
0.00%
0/106
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.00%
0/105
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/105
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Aspartate Aminotransferase Increased
|
0.95%
1/105
|
0.00%
0/106
|
Other adverse events
| Measure |
AZD0530 , Paclitaxel , Carboplatin i.v.
n=105 participants at risk
AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
|
Carboplatin ,Paclitaxel
n=106 participants at risk
Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
45/105
|
35.8%
38/106
|
|
Blood and lymphatic system disorders
Anaemia
|
38.1%
40/105
|
32.1%
34/106
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.7%
28/105
|
29.2%
31/106
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.2%
17/105
|
7.5%
8/106
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.7%
7/105
|
0.00%
0/106
|
|
Gastrointestinal disorders
Nausea
|
64.8%
68/105
|
60.4%
64/106
|
|
Gastrointestinal disorders
Diarrhoea
|
41.9%
44/105
|
34.0%
36/106
|
|
Gastrointestinal disorders
Vomiting
|
41.0%
43/105
|
36.8%
39/106
|
|
Gastrointestinal disorders
Constipation
|
25.7%
27/105
|
28.3%
30/106
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
15/105
|
20.8%
22/106
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
12.4%
13/105
|
9.4%
10/106
|
|
Gastrointestinal disorders
Stomatitis
|
5.7%
6/105
|
9.4%
10/106
|
|
General disorders
Fatigue
|
35.2%
37/105
|
39.6%
42/106
|
|
General disorders
Asthenia
|
34.3%
36/105
|
28.3%
30/106
|
|
General disorders
Pyrexia
|
21.0%
22/105
|
10.4%
11/106
|
|
General disorders
Oedema Peripheral
|
2.9%
3/105
|
8.5%
9/106
|
|
General disorders
Mucosal Inflammation
|
5.7%
6/105
|
6.6%
7/106
|
|
General disorders
Malaise
|
2.9%
3/105
|
5.7%
6/106
|
|
Immune system disorders
Drug Hypersensitivity
|
15.2%
16/105
|
22.6%
24/106
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
8/105
|
14.2%
15/106
|
|
Infections and infestations
Urinary Tract Infection
|
10.5%
11/105
|
8.5%
9/106
|
|
Infections and infestations
Cystitis
|
7.6%
8/105
|
1.9%
2/106
|
|
Infections and infestations
Weight Decreased
|
5.7%
6/105
|
4.7%
5/106
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
31.4%
33/105
|
20.8%
22/106
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.5%
11/105
|
1.9%
2/106
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.6%
8/105
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.9%
3/105
|
5.7%
6/106
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.2%
16/105
|
24.5%
26/106
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.1%
19/105
|
23.6%
25/106
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.8%
5/105
|
12.3%
13/106
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/105
|
8.5%
9/106
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
4.8%
5/105
|
8.5%
9/106
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.7%
6/105
|
7.5%
8/106
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
26.7%
28/105
|
24.5%
26/106
|
|
Nervous system disorders
Neuropathy Peripheral
|
16.2%
17/105
|
22.6%
24/106
|
|
Nervous system disorders
Headache
|
8.6%
9/105
|
13.2%
14/106
|
|
Nervous system disorders
Paraesthesia
|
7.6%
8/105
|
13.2%
14/106
|
|
Nervous system disorders
Dizziness
|
4.8%
5/105
|
10.4%
11/106
|
|
Nervous system disorders
Dysgeusia
|
7.6%
8/105
|
5.7%
6/106
|
|
Psychiatric disorders
Anxiety
|
0.95%
1/105
|
14.2%
15/106
|
|
Psychiatric disorders
Insomnia
|
5.7%
6/105
|
8.5%
9/106
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.6%
9/105
|
17.9%
19/106
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
11/105
|
16.0%
17/106
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.6%
9/105
|
5.7%
6/106
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.4%
55/105
|
60.4%
64/106
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
15/105
|
12.3%
13/106
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
3/105
|
8.5%
9/106
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
7/105
|
2.8%
3/106
|
|
Vascular disorders
Hypertension
|
2.9%
3/105
|
5.7%
6/106
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites.
- Publication restrictions are in place
Restriction type: OTHER