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Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

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: NCT01063517
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : April 30, 2015
Last Update Posted : July 20, 2023
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
Condition Gastric Cancer
Interventions Drug: olaparib
Drug: paclitaxel
Drug: Placebo
Enrollment 124
Recruitment Details This study was conducted at 13 sites in South Korea. Enrolment started in February 2010 and was completed in May 2012. In total 124 patients were randomised in the study (62 in the olaparib+paclitaxel arm and 62 in the placebo+paclitaxel arm).
Pre-assignment Details Patients of either sex, age more than 17 years with recurrent or metastatic gastric cancer that had progressed following first line therapy, a confirmed Ataxia Telangiectasia Mutation (ATM) status, Eastern Co operative Oncology Group (ECOG) performance status ≤2, normal organ and bone marrow function, and life expectancy ≥16 weeks.
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy. Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Period Title: Overall Study
Started 62 62
Received Randomised Treatment 61 62
Completed 4 2
Not Completed 58 60
Reason Not Completed
Consent withdrawal             1             0
Study reached data cut-off             19             7
Lost to Follow-up             4             3
Withdrawal by Subject             1             2
Death             33             48
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel Total
Hide Arm/Group Description Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy. Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy. Total of all reporting groups
Overall Number of Baseline Participants 62 62 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 62 participants 124 participants
59.0  (11.61) 59.4  (11.98) 59.2  (11.75)
[1]
Measure Description: Age at time of randomisation
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 62 participants 62 participants 124 participants
< 50 years 13 10 23
>=50 to <65 years 22 30 52
>= 65 years 27 22 49
[1]
Measure Description: Age category
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 124 participants
Female
13
  21.0%
18
  29.0%
31
  25.0%
Male
49
  79.0%
44
  71.0%
93
  75.0%
[1]
Measure Description: Gender
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 62 participants 62 participants 124 participants
Asian 62 62 124
Other 0 0 0
[1]
Measure Description: Race
ATM status   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 62 participants 62 participants 124 participants
Negative 31 32 63
Positive 31 30 61
[1]
Measure Description: Ataxia-Telangiectasia Mutation (ATM) protein testing
1.Primary Outcome
Title Progression Free Survival (PFS) in the Overall Study Population
Hide Description PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.
Time Frame Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including all randomised patients
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 62 62
Median (Inter-Quartile Range)
Unit of Measure: months
3.91
(3.02 to 7.13)
3.55
(1.74 to 5.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib+Paclitaxel, Placebo+Paclitaxel
Comments The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8
Confidence Interval (2-Sided) 80%
0.62 to 1.03
Estimation Comments The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.
2.Primary Outcome
Title Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]
Hide Description PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.
Time Frame Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including randomised ATM negative patients
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 31 32
Median (Inter-Quartile Range)
Unit of Measure: months
5.29
(3.38 to 5.72)
3.68
(1.77 to 5.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib+Paclitaxel, Placebo+Paclitaxel
Comments The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 80%
0.51 to 1.08
Estimation Comments The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.
3.Secondary Outcome
Title Overall Survival (OS) in the Overall Study Population
Hide Description Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.
Time Frame Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including all randomised patients
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 62 62
Median (Inter-Quartile Range)
Unit of Measure: months
13.1 [1] 
(7.10 to NA)
8.3
(5.30 to 14.90)
[1]
NA: There were insufficient events to calculate.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib+Paclitaxel, Placebo+Paclitaxel
Comments The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.56
Confidence Interval (2-Sided) 80%
0.41 to 0.75
Estimation Comments The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.
4.Secondary Outcome
Title Overall Survival (OS) in ATM Negative Patients
Hide Description Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.
Time Frame Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including randomised ATM negative patients
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 31 32
Median (Inter-Quartile Range)
Unit of Measure: months
NA [1] 
(9.30 to NA)
8.20
(5.10 to 13.10)
[1]
More than 50% of patients were alive at the data cut-off date
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib+Paclitaxel, Placebo+Paclitaxel
Comments The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.35
Confidence Interval (2-Sided) 80%
0.22 to 0.56
Estimation Comments The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.
5.Secondary Outcome
Title Objective Response Rate (ORR) in the Overall Study Population
Hide Description Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Time Frame Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response population - randomised patients having measurable disease at baseline.
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 53 47
Measure Type: Number
Unit of Measure: Participants
14 9
6.Secondary Outcome
Title Objective Response Rate (ORR) in the ATM Negative Patients
Hide Description Objective response rate is the proportion of ATM negative patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Time Frame Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 26 23
Measure Type: Number
Unit of Measure: Participants
9 6
7.Secondary Outcome
Title Percentage Change in Tumour Size at Week 8 in the Overall Study Population
Hide Description Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)
Time Frame Tumour scans done at Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response population - randomised patients having measurable disease at baseline.
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 52 47
Mean (Standard Deviation)
Unit of Measure: Percent change
-5.8  (29.09) 2.2  (35.6)
8.Secondary Outcome
Title Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients
Hide Description Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)
Time Frame Tumour scans done at Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 26 23
Mean (Standard Deviation)
Unit of Measure: Percent change
-6.9  (29.31) -5.9  (26.36)
9.Secondary Outcome
Title Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population
Hide Description Time calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Time Frame Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients having global score calculated at baseline and at least one post baseline visit
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 61 60
Median (Inter-Quartile Range)
Unit of Measure: months
3.6
(1.1 to 8.3)
2.8
(1.8 to 5.7)
10.Secondary Outcome
Title Time to Deterioration in QoL Fatigue Score in the Overall Study Population
Hide Description Time calculated from randomisation till worsening of fatigue score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Time Frame Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients having fatigue score calculated at baseline and at least one post baseline visit
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 61 60
Median (Inter-Quartile Range)
Unit of Measure: months
1.9 [1] 
(0.9 to NA)
1.8
(0.9 to 5.1)
[1]
NA: There were insufficient events to calculate.
11.Secondary Outcome
Title Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population
Hide Description Time calculated from randomisation till worsening of nausea & vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Time Frame Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients having nausea & vomiting domain score calculated at baseline and at least one post baseline visit
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 61 60
Median (Inter-Quartile Range)
Unit of Measure: months
3.7
(1.65 to 13.9)
3.7
(1.8 to 7.6)
12.Secondary Outcome
Title Time to Deterioration in QoL Pain Domain Score in the Overall Study Population
Hide Description Time calculated from randomisation till worsening of pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Time Frame Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients having pain domain score calculated at baseline and at least one post baseline visit
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 61 60
Median (Inter-Quartile Range)
Unit of Measure: months
3.2
(1.8 to 5.5)
3.1
(1.0 to 5.7)
13.Secondary Outcome
Title Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population
Hide Description Time calculated from randomisation till worsening of dysphagia domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Time Frame Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients having dysphagia domain score calculated at baseline and at least one post baseline visit
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 61 60
Median (Inter-Quartile Range)
Unit of Measure: months
3.7
(2.2 to 12.6)
1.9
(0.9 to 6.4)
14.Secondary Outcome
Title Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population
Hide Description Time calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Time Frame Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients having eating restriction domain score calculated at baseline and at least one post baseline visit
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 61 60
Median (Inter-Quartile Range)
Unit of Measure: months
4.6
(2.5 to 12.9)
5.1
(2.2 to 8.9)
15.Secondary Outcome
Title Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population
Hide Description Time calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Time Frame Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients having stomach pain domain score calculated at baseline and at least one post baseline visit
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 61 60
Median (Inter-Quartile Range)
Unit of Measure: months
6.9 [1] 
(3.7 to NA)
5.7
(2.8 to 9.2)
[1]
NA: There were insufficient events to calculate.
16.Secondary Outcome
Title Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population
Hide Description Time calculated from randomisation till worsening of reflux domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Time Frame Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients having reflux domain score calculated at baseline and at least one post baseline visit
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 61 60
Median (Inter-Quartile Range)
Unit of Measure: months
4.3
(2.1 to 13.9)
2.8
(1.0 to 5.7)
17.Secondary Outcome
Title Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population
Hide Description Time calculated from randomisation till worsening of anxiety domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Time Frame Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomised patients having anxiety domain score calculated at baseline and at least one post baseline visit
Arm/Group Title Olaparib+Paclitaxel Placebo+Paclitaxel
Hide Arm/Group Description:
Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
Overall Number of Participants Analyzed 61 60
Median (Inter-Quartile Range)
Unit of Measure: months
2.8
(1.1 to 12.2)
1.9
(1.0 to 5.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/61 (27.87%)      23/62 (37.10%)    
Blood and lymphatic system disorders     
FEBRILE NEUTROPENIA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
NEUTROPENIA † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
Gastrointestinal disorders     
COLITIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
DIARRHOEA † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
GASTROINTESTINAL HAEMORRHAGE † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
HAEMATEMESIS † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
HAEMORRHOIDS † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
OBSTRUCTION GASTRIC † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
UPPER GASTROINTESTINAL HAEMORRHAGE † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
VOMITING † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
General disorders     
ASTHENIA † 1  1/61 (1.64%)  1 2/62 (3.23%)  2
FATIGUE † 1  2/61 (3.28%)  2 2/62 (3.23%)  2
PAIN † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
PYREXIA † 1  1/61 (1.64%)  1 2/62 (3.23%)  2
Hepatobiliary disorders     
CHOLANGITIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
HYPERBILIRUBINAEMIA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
JAUNDICE † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Infections and infestations     
RESPIRATORY TRACT INFECTION † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
APPENDICITIS † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
CYSTITIS † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
ENTEROCOLITIS INFECTIOUS † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
HERPES ZOSTER † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
LOWER RESPIRATORY TRACT INFECTION † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
PNEUMONIA † 1  3/61 (4.92%)  3 6/62 (9.68%)  6
URINARY TRACT INFECTION † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Injury, poisoning and procedural complications     
LIGAMENT SPRAIN † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Investigations     
ALANINE AMINOTRANSFERASE INCREASED † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Metabolism and nutrition disorders     
DECREASED APPETITE † 1  1/61 (1.64%)  1 2/62 (3.23%)  2
Nervous system disorders     
CEREBRAL INFARCTION † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
CEREBRAL ISCHAEMIA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
SYNCOPE † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Psychiatric disorders     
DELIRIUM † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
ALCOHOLISM † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
Renal and urinary disorders     
HYDRONEPHROSIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Respiratory, thoracic and mediastinal disorders     
PNEUMONITIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
PULMONARY EMBOLISM † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Vascular disorders     
HYPOTENSION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
THROMBOSIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/61 (100.00%)      62/62 (100.00%)    
Blood and lymphatic system disorders     
ANAEMIA † 1  11/61 (18.03%)  17 12/62 (19.35%)  23
FEBRILE NEUTROPENIA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
IRON DEFICIENCY ANAEMIA † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
LEUKOPENIA † 1  5/61 (8.20%)  5 3/62 (4.84%)  3
NEUTROPENIA † 1  46/61 (75.41%)  162 40/62 (64.52%)  127
THROMBOCYTOPENIA † 1  0/61 (0.00%)  0 3/62 (4.84%)  3
Cardiac disorders     
ANGINA PECTORIS † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
PALPITATIONS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Ear and labyrinth disorders     
EAR PAIN † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
Eye disorders     
CATARACT † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
DRY EYE † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
EYE PAIN † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
PTERYGIUM † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
VISION BLURRED † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL DISCOMFORT † 1  4/61 (6.56%)  4 0/62 (0.00%)  0
ABDOMINAL DISTENSION † 1  4/61 (6.56%)  4 5/62 (8.06%)  5
ABDOMINAL PAIN † 1  15/61 (24.59%)  18 16/62 (25.81%)  19
ABDOMINAL PAIN LOWER † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
ABDOMINAL PAIN UPPER † 1  8/61 (13.11%)  9 8/62 (12.90%)  10
ASCITES † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
BREATH ODOUR † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
CHEILITIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
DIARRHOEA † 1  20/61 (32.79%)  34 17/62 (27.42%)  28
DRY MOUTH † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
DYSPEPSIA † 1  11/61 (18.03%)  16 10/62 (16.13%)  13
EPIGASTRIC DISCOMFORT † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
ERUCTATION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE † 1  1/61 (1.64%)  1 2/62 (3.23%)  2
GINGIVAL PAIN † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
GINGIVITIS † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
HAEMATEMESIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
LIP PAIN † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
MOUTH ULCERATION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
NAUSEA † 1  21/61 (34.43%)  26 26/62 (41.94%)  32
ORAL PAIN † 1  1/61 (1.64%)  2 0/62 (0.00%)  0
REFLUX GASTRITIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
STOMATITIS † 1  3/61 (4.92%)  3 3/62 (4.84%)  6
TOOTHACHE † 1  3/61 (4.92%)  3 1/62 (1.61%)  1
VOMITING † 1  9/61 (14.75%)  11 14/62 (22.58%)  16
CONSTIPATION † 1  14/61 (22.95%)  15 10/62 (16.13%)  11
MELAENA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
PROCTALGIA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
General disorders     
CHILLS † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
FACE OEDEMA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
FATIGUE † 1  15/61 (24.59%)  15 19/62 (30.65%)  24
GENERALISED OEDEMA † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
INFLUENZA LIKE ILLNESS † 1  2/61 (3.28%)  5 3/62 (4.84%)  3
IRRITABILITY † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
LOCALISED OEDEMA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
MUCOSAL INFLAMMATION † 1  4/61 (6.56%)  4 1/62 (1.61%)  1
NON-CARDIAC CHEST PAIN † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
OEDEMA † 1  1/61 (1.64%)  1 2/62 (3.23%)  2
OEDEMA PERIPHERAL † 1  3/61 (4.92%)  3 6/62 (9.68%)  7
PAIN † 1  3/61 (4.92%)  3 2/62 (3.23%)  2
PYREXIA † 1  6/61 (9.84%)  7 13/62 (20.97%)  16
ASTHENIA † 1  19/61 (31.15%)  29 15/62 (24.19%)  22
Hepatobiliary disorders     
HEPATOTOXICITY † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
JAUNDICE † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
LIVER DISORDER † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
HYPERBILIRUBINAEMIA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
Infections and infestations     
ANAL ABSCESS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
BRONCHIOLITIS † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
BRONCHOPNEUMONIA † 1  2/61 (3.28%)  2 0/62 (0.00%)  0
HERPES ZOSTER † 1  2/61 (3.28%)  2 1/62 (1.61%)  1
NASOPHARYNGITIS † 1  3/61 (4.92%)  5 4/62 (6.45%)  7
PHARYNGITIS † 1  1/61 (1.64%)  1 2/62 (3.23%)  2
PNEUMONIA † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
RASH PUSTULAR † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
RHINITIS † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
TONSILLITIS † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION † 1  5/61 (8.20%)  9 5/62 (8.06%)  5
BRONCHITIS † 1  1/61 (1.64%)  1 2/62 (3.23%)  2
FURUNCLE † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
HERPES VIRUS INFECTION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
PARONYCHIA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
SEPSIS † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
Injury, poisoning and procedural complications     
EXCORIATION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
PROCEDURAL PAIN † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
Investigations     
AMYLASE INCREASED † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED † 1  5/61 (8.20%)  6 4/62 (6.45%)  5
BLOOD ALKALINE PHOSPHATASE INCREASED † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
BLOOD BILIRUBIN INCREASED † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
BLOOD CREATININE INCREASED † 1  1/61 (1.64%)  4 0/62 (0.00%)  0
GAMMA-GLUTAMYLTRANSFERASE INCREASED † 1  3/61 (4.92%)  3 5/62 (8.06%)  5
HAEMOGLOBIN † 1  0/61 (0.00%)  0 1/62 (1.61%)  3
HAEMOGLOBIN DECREASED † 1  2/61 (3.28%)  2 2/62 (3.23%)  2
NEUTROPHIL COUNT DECREASED † 1  2/61 (3.28%)  11 1/62 (1.61%)  1
WEIGHT DECREASED † 1  4/61 (6.56%)  4 1/62 (1.61%)  1
WHITE BLOOD CELL COUNT DECREASED † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
ALANINE AMINOTRANSFERASE INCREASED † 1  4/61 (6.56%)  5 4/62 (6.45%)  6
Metabolism and nutrition disorders     
DECREASED APPETITE † 1  23/61 (37.70%)  30 25/62 (40.32%)  34
HYPERGLYCAEMIA † 1  3/61 (4.92%)  4 2/62 (3.23%)  2
HYPERKALAEMIA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
HYPERMAGNESAEMIA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
HYPOALBUMINAEMIA † 1  1/61 (1.64%)  2 3/62 (4.84%)  3
HYPOCALCAEMIA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
HYPOKALAEMIA † 1  0/61 (0.00%)  0 4/62 (6.45%)  4
HYPOMAGNESAEMIA † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
HYPONATRAEMIA † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
Musculoskeletal and connective tissue disorders     
ARTHRALGIA † 1  2/61 (3.28%)  2 4/62 (6.45%)  4
BACK PAIN † 1  3/61 (4.92%)  3 6/62 (9.68%)  7
BONE PAIN † 1  0/61 (0.00%)  0 4/62 (6.45%)  8
FLANK PAIN † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
MUSCULOSKELETAL CHEST PAIN † 1  2/61 (3.28%)  4 2/62 (3.23%)  2
MUSCULOSKELETAL PAIN † 1  1/61 (1.64%)  1 1/62 (1.61%)  4
MYALGIA † 1  10/61 (16.39%)  17 22/62 (35.48%)  32
NECK PAIN † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
PAIN IN EXTREMITY † 1  3/61 (4.92%)  3 3/62 (4.84%)  4
POLYMYALGIA RHEUMATICA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Nervous system disorders     
DIZZINESS † 1  11/61 (18.03%)  12 7/62 (11.29%)  14
HYPOAESTHESIA † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
LUMBAR RADICULOPATHY † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
NEUROPATHY PERIPHERAL † 1  22/61 (36.07%)  22 13/62 (20.97%)  15
PARAESTHESIA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
PERIPHERAL SENSORY NEUROPATHY † 1  8/61 (13.11%)  8 10/62 (16.13%)  11
SYNCOPE † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
DYSGEUSIA † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
HEADACHE † 1  3/61 (4.92%)  3 4/62 (6.45%)  5
Psychiatric disorders     
ANXIETY † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
DISORIENTATION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
MENTAL DISORDER † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
MOOD ALTERED † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
DEPRESSION † 1  1/61 (1.64%)  1 3/62 (4.84%)  3
INSOMNIA † 1  7/61 (11.48%)  8 4/62 (6.45%)  6
Renal and urinary disorders     
DYSURIA † 1  3/61 (4.92%)  3 5/62 (8.06%)  5
HAEMOGLOBINURIA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
HYDRONEPHROSIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
MICTURITION URGENCY † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
NOCTURIA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
POLLAKIURIA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
URETHRAL PAIN † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
URINARY RETENTION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
Reproductive system and breast disorders     
GENITAL RASH † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
PELVIC DISCOMFORT † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
COUGH † 1  10/61 (16.39%)  10 7/62 (11.29%)  8
DYSPHONIA † 1  0/61 (0.00%)  0 3/62 (4.84%)  3
DYSPNOEA † 1  2/61 (3.28%)  2 10/62 (16.13%)  13
DYSPNOEA EXERTIONAL † 1  0/61 (0.00%)  0 2/62 (3.23%)  2
EPISTAXIS † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
HAEMOPTYSIS † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
HICCUPS † 1  2/61 (3.28%)  2 4/62 (6.45%)  5
NASAL CONGESTION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
NASAL DISCOMFORT † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
ORGANISING PNEUMONIA † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
OROPHARYNGEAL PAIN † 1  4/61 (6.56%)  4 3/62 (4.84%)  3
PRODUCTIVE COUGH † 1  0/61 (0.00%)  0 7/62 (11.29%)  8
PULMONARY EMBOLISM † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
SPUTUM INCREASED † 1  2/61 (3.28%)  2 2/62 (3.23%)  2
TONSILLAR INFLAMMATION † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
RHINORRHOEA † 1  7/61 (11.48%)  11 0/62 (0.00%)  0
Skin and subcutaneous tissue disorders     
ALOPECIA † 1  30/61 (49.18%)  30 29/62 (46.77%)  29
BLISTER † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
DERMATITIS ACNEIFORM † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
HYPERHIDROSIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
NAIL DISORDER † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
ONYCHOLYSIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
PRURITUS † 1  8/61 (13.11%)  11 3/62 (4.84%)  4
RASH † 1  8/61 (13.11%)  10 8/62 (12.90%)  11
SKIN DISORDER † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
SKIN HYPERPIGMENTATION † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
URTICARIA † 1  1/61 (1.64%)  1 0/62 (0.00%)  0
Vascular disorders     
HOT FLUSH † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
HYPOTENSION † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
PERIPHERAL COLDNESS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
PHLEBITIS † 1  1/61 (1.64%)  1 1/62 (1.61%)  1
THROMBOSIS † 1  0/61 (0.00%)  0 1/62 (1.61%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anitra Fielding
Organization: AstraZeneca
Phone: +44 1625 517178
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01063517    
Other Study ID Numbers: D0810C00039
First Submitted: February 4, 2010
First Posted: February 5, 2010
Results First Submitted: January 13, 2015
Results First Posted: April 30, 2015
Last Update Posted: July 20, 2023