efficacy study of olaparib with paclitaxel versus paclitaxel in gastric cancer patients

Study identifier:D0810C00039

ClinicalTrials.gov identifier:NCT01063517

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomised, double blinded, multicentre phase II study to assess the efficacy of olaparib (AZD2281, KU-0059436) in combination with paclitaxel versus paclitaxel in patients with recurrent or metastatic gastric cancer who progress following first-line therapy

Medical condition

gastric cancer

Phase

Phase 2

Healthy volunteers

Study drug

olaparib, paclitaxel, Placebo

Sex

All

Actual Enrollment

124

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 02 Feb 2010

Primary Completion Date: 11 May 2012

Study Completion Date: 29 Jun 2023

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Seoul, Republic of Korea, 137-701

Location

Research Site

Taegu, Republic of Korea, 705-035

Location

Research Site

Seoul, Republic of Korea, 134-791

Location

Research Site

Jeonnam, Republic of Korea, 519-763

Location

Research Site

Seoul, Republic of Korea, 03722

Location

Research Site

Goyang-si, Republic of Korea, 410-769

Location

Research Site

Seoul, Republic of Korea, 110-744

Arms	Assigned Interventions
Experimental: 1 Olaparib + paclitaxel	Drug: olaparib 100mg BID oral tablet continuous Drug: paclitaxel iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle Other Name: Taxol
Active Comparator: 2 paclitaxel + placebo	Drug: paclitaxel iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle Other Name: Taxol Drug: Placebo 100mg BID oral tablet to match olaparib tablet

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Participant Flow: Overall Study

	Olaparib+Paclitaxel	Placebo+Paclitaxel
STARTED	62	62
Received randomised treatment	61	62
COMPLETED	4	2
NOT COMPLETED	58	60
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

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Baseline Measures

	Olaparib+Paclitaxel	Placebo+Paclitaxel	Total
Number of Participants [units: Participants]	62	62	124
Age Continuous ^[1] [units: years] Mean ± Standard Deviation	59.0 ± 11.61	59.4 ± 11.98	59.2 ± 11.75
Gender, Male/Female ^[2] [units: ]
Female	13	18	31
Male	49	44	93
Race/Ethnicity, Customized ^[3] [units: Participants]
Asian	62	62	124
Other	0	0	0
Age, Customized ^[4] [units: Participants]
< 50 years	13	10	23
>=50 to <65 years	22	30	52
>= 65 years	27	22	49
ATM status ^[5] [units: Participants]
Negative	31	32	63
Positive	31	30	61

Outcome Measures

1. Primary Outcome Measure: Progression free survival (PFS) in the overall study population [ 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 ]

Measure Type	Primary
Measure Name	Progression free survival (PFS) in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set including all randomised patients

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	62	62
Progression free survival (PFS) in the overall study population [units: months] Median (Inter-Quartile Range)	3.91 (3.02 to 7.13)	3.55 (1.74 to 5.82)

Statistical Analysis 1 for Progression free survival (PFS) in the overall study population

Groups^[1]	All groups
Hazard Ratio (HR)^[5]	0.8
80% Confidence Interval	( 0.62 to 1.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).
[5]	Other relevant estimation information:
	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 Measure: Progression free survival (PFS) in patients with tumours defined as Homologous Recombination Deficient by loss of Ataxia-Telangiectasia Mutation (ATM) protein [ATM negative patients] [ 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 ]

Measure Type	Primary
Measure Name	Progression free survival (PFS) in patients with tumours defined as Homologous Recombination Deficient by loss of Ataxia-Telangiectasia Mutation (ATM) protein [ATM negative patients]
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set including randomised ATM negative patients

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	31	32
Progression free survival (PFS) in patients with tumours defined as Homologous Recombination Deficient by loss of Ataxia-Telangiectasia Mutation (ATM) protein [ATM negative patients] [units: months] Median (Inter-Quartile Range)	5.29 (3.38 to 5.72)	3.68 (1.77 to 5.82)

Statistical Analysis 1 for Progression free survival (PFS) in patients with tumours defined as Homologous Recombination Deficient by loss of Ataxia-Telangiectasia Mutation (ATM) protein [ATM negative patients]

Groups^[1]	All groups
Hazard Ratio (HR)^[5]	0.74
80% Confidence Interval	( 0.51 to 1.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).
[5]	Other relevant estimation information:
	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 Measure: Overall survival (OS) in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Overall survival (OS) in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set including all randomised patients

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	62	62
Overall survival (OS) in the overall study population [units: months] Median (Inter-Quartile Range)	13.1 (7.10 to NA) ^[1]	8.3 (5.30 to 14.90)

Statistical Analysis 1 for Overall survival (OS) in the overall study population

Groups^[1]	All groups
Hazard Ratio (HR)^[5]	0.56
80% Confidence Interval	( 0.41 to 0.75 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).
[5]	Other relevant estimation information:
	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 Measure: Overall survival (OS) in ATM negative patients [ 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 ]

Measure Type	Secondary
Measure Name	Overall survival (OS) in ATM negative patients
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set including randomised ATM negative patients

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	31	32
Overall survival (OS) in ATM negative patients [units: months] Median (Inter-Quartile Range)	NA (9.30 to NA) ^[1]	8.20 (5.10 to 13.10)

Statistical Analysis 1 for Overall survival (OS) in ATM negative patients

Groups^[1]	All groups
Hazard Ratio (HR)^[5]	0.35
80% Confidence Interval	( 0.22 to 0.56 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).
[5]	Other relevant estimation information:
	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 Measure: Objective response rate (ORR) in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Objective response rate (ORR) in the overall study population
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable for response population - randomised patients having measurable disease at baseline.

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	53	47
Objective response rate (ORR) in the overall study population [units: Participants]	14	9

No statistical analysis provided for Objective response rate (ORR) in the overall study population

6. Secondary Outcome Measure: Objective response rate (ORR) in the ATM negative patients [ 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 ]

Measure Type	Secondary
Measure Name	Objective response rate (ORR) in the ATM negative patients
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	26	23
Objective response rate (ORR) in the ATM negative patients [units: Participants]	9	6

No statistical analysis provided for Objective response rate (ORR) in the ATM negative patients

7. Secondary Outcome Measure: Percentage change in tumour size at Week 8 in the overall study population [ Time Frame: Tumour scans done at Baseline and week 8 ]

Measure Type	Secondary
Measure Name	Percentage change in tumour size at Week 8 in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable for response population - randomised patients having measurable disease at baseline.

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	52	47
Percentage change in tumour size at Week 8 in the overall study population [units: Percent change] Mean (Standard Deviation)	-5.8 (29.09)	2.2 (35.6)

No statistical analysis provided for Percentage change in tumour size at Week 8 in the overall study population

8. Secondary Outcome Measure: Percentage change in tumour size at Week 8 in the ATM negative patients [ Time Frame: Tumour scans done at Baseline and week 8 ]

Measure Type	Secondary
Measure Name	Percentage change in tumour size at Week 8 in the ATM negative patients
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	26	23
Percentage change in tumour size at Week 8 in the ATM negative patients [units: Percent change] Mean (Standard Deviation)	-6.9 (29.31)	-5.9 (26.36)

No statistical analysis provided for Percentage change in tumour size at Week 8 in the ATM negative patients

9. Secondary Outcome Measure: Time to deterioration in Global Quality of Life (QoL) score in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Time to deterioration in Global Quality of Life (QoL) score in the overall study population
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised patients having global score calculated at baseline and at least one post baseline visit

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	61	60
Time to deterioration in Global Quality of Life (QoL) score in the overall study population [units: months] Median (Inter-Quartile Range)	3.6 (1.1 to 8.3)	2.8 (1.8 to 5.7)

No statistical analysis provided for Time to deterioration in Global Quality of Life (QoL) score in the overall study population

10. Secondary Outcome Measure: Time to deterioration in QoL fatigue score in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Time to deterioration in QoL fatigue score in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised patients having fatigue score calculated at baseline and at least one post baseline visit

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	61	60
Time to deterioration in QoL fatigue score in the overall study population [units: months] Median (Inter-Quartile Range)	1.9 (0.9 to NA) ^[1]	1.8 (0.9 to 5.1)

No statistical analysis provided for Time to deterioration in QoL fatigue score in the overall study population

11. Secondary Outcome Measure: Time to deterioration in QoL nausea & vomiting domain score in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Time to deterioration in QoL nausea & vomiting domain score in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised patients having nausea & vomiting domain score calculated at baseline and at least one post baseline visit

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	61	60
Time to deterioration in QoL nausea & vomiting domain score in the overall study population [units: months] Median (Inter-Quartile Range)	3.7 (1.65 to 13.9)	3.7 (1.8 to 7.6)

No statistical analysis provided for Time to deterioration in QoL nausea & vomiting domain score in the overall study population

12. Secondary Outcome Measure: Time to deterioration in QoL pain domain score in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Time to deterioration in QoL pain domain score in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised patients having pain domain score calculated at baseline and at least one post baseline visit

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	61	60
Time to deterioration in QoL pain domain score in the overall study population [units: months] Median (Inter-Quartile Range)	3.2 (1.8 to 5.5)	3.1 (1.0 to 5.7)

No statistical analysis provided for Time to deterioration in QoL pain domain score in the overall study population

13. Secondary Outcome Measure: Time to deterioration in QoL dysphagia domain score in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Time to deterioration in QoL dysphagia domain score in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised patients having dysphagia domain score calculated at baseline and at least one post baseline visit

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	61	60
Time to deterioration in QoL dysphagia domain score in the overall study population [units: months] Median (Inter-Quartile Range)	3.7 (2.2 to 12.6)	1.9 (0.9 to 6.4)

No statistical analysis provided for Time to deterioration in QoL dysphagia domain score in the overall study population

14. Secondary Outcome Measure: Time to deterioration in QoL eating restriction domain score in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Time to deterioration in QoL eating restriction domain score in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised patients having eating restriction domain score calculated at baseline and at least one post baseline visit

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	61	60
Time to deterioration in QoL eating restriction domain score in the overall study population [units: months] Median (Inter-Quartile Range)	4.6 (2.5 to 12.9)	5.1 (2.2 to 8.9)

No statistical analysis provided for Time to deterioration in QoL eating restriction domain score in the overall study population

15. Secondary Outcome Measure: Time to deterioration in QoL stomach pain domain score in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Time to deterioration in QoL stomach pain domain score in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised patients having stomach pain domain score calculated at baseline and at least one post baseline visit

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	61	60
Time to deterioration in QoL stomach pain domain score in the overall study population [units: months] Median (Inter-Quartile Range)	6.9 (3.7 to NA) ^[1]	5.7 (2.8 to 9.2)

No statistical analysis provided for Time to deterioration in QoL stomach pain domain score in the overall study population

16. Secondary Outcome Measure: Time to deterioration in QoL reflux domain score in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Time to deterioration in QoL reflux domain score in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised patients having reflux domain score calculated at baseline and at least one post baseline visit

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	61	60
Time to deterioration in QoL reflux domain score in the overall study population [units: months] Median (Inter-Quartile Range)	4.3 (2.1 to 13.9)	2.8 (1.0 to 5.7)

No statistical analysis provided for Time to deterioration in QoL reflux domain score in the overall study population

17. Secondary Outcome Measure: Time to deterioration in QoL anxiety domain score in the overall study population [ 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 ]

Measure Type	Secondary
Measure Name	Time to deterioration in QoL anxiety domain score in the overall study population
Measure 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
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised patients having anxiety domain score calculated at baseline and at least one post baseline visit

Reporting Groups

	Description
Olaparib+Paclitaxel	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.
Placebo+Paclitaxel	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.

Measured Values

	Olaparib+Paclitaxel	Placebo+Paclitaxel
Number of Participants Analyzed [units:participants]	61	60
Time to deterioration in QoL anxiety domain score in the overall study population [units: months] Median (Inter-Quartile Range)	2.8 (1.1 to 12.2)	1.9 (1.0 to 5.1)

No statistical analysis provided for Time to deterioration in QoL anxiety domain score in the overall study population

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD	No text entered.
PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD	No text entered.

Serious Adverse Events

OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD

PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD

Total, serious adverse events

# participants affected / at risk

17/61 (27.87%)

23/62 (37.10%)

BLOOD AND LYMPHATIC SYSTEM DISORDERS

FEBRILE NEUTROPENIA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

BLOOD AND LYMPHATIC SYSTEM DISORDERS

NEUTROPENIA¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

CARDIAC DISORDERS

ACUTE MYOCARDIAL INFARCTION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

ASTHENIA¹,^†

# participants affected / at risk

1/61 (1.64%)

2/62 (3.23%)

# events

HEPATOBILIARY DISORDERS

CHOLANGITIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

HEPATOBILIARY DISORDERS

HYPERBILIRUBINAEMIA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

RESPIRATORY TRACT INFECTION¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

LIGAMENT SPRAIN¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INVESTIGATIONS

ALANINE AMINOTRANSFERASE INCREASED¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

PSYCHIATRIC DISORDERS

DELIRIUM¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

COLITIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

DIARRHOEA¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

GASTROINTESTINAL HAEMORRHAGE¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

HAEMATEMESIS¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

HAEMORRHOIDS¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

OBSTRUCTION GASTRIC¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

UPPER GASTROINTESTINAL HAEMORRHAGE¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

VOMITING¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

FATIGUE¹,^†

# participants affected / at risk

2/61 (3.28%)

2/62 (3.23%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

PAIN¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

PYREXIA¹,^†

# participants affected / at risk

1/61 (1.64%)

2/62 (3.23%)

# events

HEPATOBILIARY DISORDERS

JAUNDICE¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

APPENDICITIS¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INFECTIONS AND INFESTATIONS

CYSTITIS¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INFECTIONS AND INFESTATIONS

ENTEROCOLITIS INFECTIOUS¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

INFECTIONS AND INFESTATIONS

HERPES ZOSTER¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

LOWER RESPIRATORY TRACT INFECTION¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

PNEUMONIA¹,^†

# participants affected / at risk

3/61 (4.92%)

6/62 (9.68%)

# events

INFECTIONS AND INFESTATIONS

URINARY TRACT INFECTION¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

METABOLISM AND NUTRITION DISORDERS

DECREASED APPETITE¹,^†

# participants affected / at risk

1/61 (1.64%)

2/62 (3.23%)

# events

NERVOUS SYSTEM DISORDERS

CEREBRAL INFARCTION¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

NERVOUS SYSTEM DISORDERS

CEREBRAL ISCHAEMIA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

NERVOUS SYSTEM DISORDERS

SYNCOPE¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

PSYCHIATRIC DISORDERS

ALCOHOLISM¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RENAL AND URINARY DISORDERS

HYDRONEPHROSIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

PNEUMONITIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

PULMONARY EMBOLISM¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

VASCULAR DISORDERS

HYPOTENSION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

VASCULAR DISORDERS

THROMBOSIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 15

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD	No text entered.
PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD	No text entered.

Other Adverse Events

OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD

PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD

Total, other (not including serious) adverse events

# participants affected / at risk

61/61 (100.00%)

62/62 (100.00%)

BLOOD AND LYMPHATIC SYSTEM DISORDERS

ANAEMIA¹,^†

# participants affected / at risk

11/61 (18.03%)

12/62 (19.35%)

# events

BLOOD AND LYMPHATIC SYSTEM DISORDERS

FEBRILE NEUTROPENIA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

BLOOD AND LYMPHATIC SYSTEM DISORDERS

IRON DEFICIENCY ANAEMIA¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

BLOOD AND LYMPHATIC SYSTEM DISORDERS

LEUKOPENIA¹,^†

# participants affected / at risk

5/61 (8.20%)

3/62 (4.84%)

# events

BLOOD AND LYMPHATIC SYSTEM DISORDERS

NEUTROPENIA¹,^†

# participants affected / at risk

46/61 (75.41%)

40/62 (64.52%)

# events

162

127

BLOOD AND LYMPHATIC SYSTEM DISORDERS

THROMBOCYTOPENIA¹,^†

# participants affected / at risk

0/61 (0.00%)

3/62 (4.84%)

# events

CARDIAC DISORDERS

ANGINA PECTORIS¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

CARDIAC DISORDERS

PALPITATIONS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

EAR AND LABYRINTH DISORDERS

EAR PAIN¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

EYE DISORDERS

CATARACT¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

EYE DISORDERS

DRY EYE¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

EYE DISORDERS

EYE PAIN¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

EYE DISORDERS

PTERYGIUM¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

EYE DISORDERS

VISION BLURRED¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

ABDOMINAL DISCOMFORT¹,^†

# participants affected / at risk

4/61 (6.56%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

ABDOMINAL DISTENSION¹,^†

# participants affected / at risk

4/61 (6.56%)

5/62 (8.06%)

# events

GASTROINTESTINAL DISORDERS

ABDOMINAL PAIN¹,^†

# participants affected / at risk

15/61 (24.59%)

16/62 (25.81%)

# events

GASTROINTESTINAL DISORDERS

ABDOMINAL PAIN LOWER¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

ABDOMINAL PAIN UPPER¹,^†

# participants affected / at risk

8/61 (13.11%)

8/62 (12.90%)

# events

GASTROINTESTINAL DISORDERS

ASCITES¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

BREATH ODOUR¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

CHEILITIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

DIARRHOEA¹,^†

# participants affected / at risk

20/61 (32.79%)

17/62 (27.42%)

# events

GASTROINTESTINAL DISORDERS

DRY MOUTH¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

DYSPEPSIA¹,^†

# participants affected / at risk

11/61 (18.03%)

10/62 (16.13%)

# events

GASTROINTESTINAL DISORDERS

EPIGASTRIC DISCOMFORT¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

ERUCTATION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

GASTROINTESTINAL HAEMORRHAGE¹,^†

# participants affected / at risk

1/61 (1.64%)

2/62 (3.23%)

# events

GASTROINTESTINAL DISORDERS

GINGIVAL PAIN¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

GINGIVITIS¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

HAEMATEMESIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

LIP PAIN¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

MOUTH ULCERATION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

NAUSEA¹,^†

# participants affected / at risk

21/61 (34.43%)

26/62 (41.94%)

# events

GASTROINTESTINAL DISORDERS

ORAL PAIN¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

REFLUX GASTRITIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

STOMATITIS¹,^†

# participants affected / at risk

3/61 (4.92%)

3/62 (4.84%)

# events

GASTROINTESTINAL DISORDERS

TOOTHACHE¹,^†

# participants affected / at risk

3/61 (4.92%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

VOMITING¹,^†

# participants affected / at risk

9/61 (14.75%)

14/62 (22.58%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

CHILLS¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

FACE OEDEMA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

FATIGUE¹,^†

# participants affected / at risk

15/61 (24.59%)

19/62 (30.65%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

GENERALISED OEDEMA¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

INFLUENZA LIKE ILLNESS¹,^†

# participants affected / at risk

2/61 (3.28%)

3/62 (4.84%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

IRRITABILITY¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

LOCALISED OEDEMA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

MUCOSAL INFLAMMATION¹,^†

# participants affected / at risk

4/61 (6.56%)

1/62 (1.61%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

NON-CARDIAC CHEST PAIN¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

OEDEMA¹,^†

# participants affected / at risk

1/61 (1.64%)

2/62 (3.23%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

OEDEMA PERIPHERAL¹,^†

# participants affected / at risk

3/61 (4.92%)

6/62 (9.68%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

PAIN¹,^†

# participants affected / at risk

3/61 (4.92%)

2/62 (3.23%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

PYREXIA¹,^†

# participants affected / at risk

6/61 (9.84%)

13/62 (20.97%)

# events

HEPATOBILIARY DISORDERS

HEPATOTOXICITY¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

HEPATOBILIARY DISORDERS

JAUNDICE¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

HEPATOBILIARY DISORDERS

LIVER DISORDER¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

ANAL ABSCESS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

BRONCHIOLITIS¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INFECTIONS AND INFESTATIONS

BRONCHOPNEUMONIA¹,^†

# participants affected / at risk

2/61 (3.28%)

0/62 (0.00%)

# events

INFECTIONS AND INFESTATIONS

HERPES ZOSTER¹,^†

# participants affected / at risk

2/61 (3.28%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

NASOPHARYNGITIS¹,^†

# participants affected / at risk

3/61 (4.92%)

4/62 (6.45%)

# events

INFECTIONS AND INFESTATIONS

PHARYNGITIS¹,^†

# participants affected / at risk

1/61 (1.64%)

2/62 (3.23%)

# events

INFECTIONS AND INFESTATIONS

PNEUMONIA¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

RASH PUSTULAR¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

RHINITIS¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

TONSILLITIS¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INFECTIONS AND INFESTATIONS

UPPER RESPIRATORY TRACT INFECTION¹,^†

# participants affected / at risk

5/61 (8.20%)

5/62 (8.06%)

# events

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

EXCORIATION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

PROCEDURAL PAIN¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INVESTIGATIONS

AMYLASE INCREASED¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INVESTIGATIONS

ASPARTATE AMINOTRANSFERASE INCREASED¹,^†

# participants affected / at risk

5/61 (8.20%)

4/62 (6.45%)

# events

INVESTIGATIONS

BLOOD ALKALINE PHOSPHATASE INCREASED¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INVESTIGATIONS

BLOOD BILIRUBIN INCREASED¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INVESTIGATIONS

BLOOD CREATININE INCREASED¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INVESTIGATIONS

GAMMA-GLUTAMYLTRANSFERASE INCREASED¹,^†

# participants affected / at risk

3/61 (4.92%)

5/62 (8.06%)

# events

INVESTIGATIONS

HAEMOGLOBIN¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INVESTIGATIONS

HAEMOGLOBIN DECREASED¹,^†

# participants affected / at risk

2/61 (3.28%)

2/62 (3.23%)

# events

INVESTIGATIONS

NEUTROPHIL COUNT DECREASED¹,^†

# participants affected / at risk

2/61 (3.28%)

1/62 (1.61%)

# events

INVESTIGATIONS

WEIGHT DECREASED¹,^†

# participants affected / at risk

4/61 (6.56%)

1/62 (1.61%)

# events

INVESTIGATIONS

WHITE BLOOD CELL COUNT DECREASED¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

METABOLISM AND NUTRITION DISORDERS

DECREASED APPETITE¹,^†

# participants affected / at risk

23/61 (37.70%)

25/62 (40.32%)

# events

METABOLISM AND NUTRITION DISORDERS

HYPERGLYCAEMIA¹,^†

# participants affected / at risk

3/61 (4.92%)

2/62 (3.23%)

# events

METABOLISM AND NUTRITION DISORDERS

HYPERKALAEMIA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

METABOLISM AND NUTRITION DISORDERS

HYPERMAGNESAEMIA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

METABOLISM AND NUTRITION DISORDERS

HYPOALBUMINAEMIA¹,^†

# participants affected / at risk

1/61 (1.64%)

3/62 (4.84%)

# events

METABOLISM AND NUTRITION DISORDERS

HYPOCALCAEMIA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

METABOLISM AND NUTRITION DISORDERS

HYPOKALAEMIA¹,^†

# participants affected / at risk

0/61 (0.00%)

4/62 (6.45%)

# events

METABOLISM AND NUTRITION DISORDERS

HYPOMAGNESAEMIA¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

METABOLISM AND NUTRITION DISORDERS

HYPONATRAEMIA¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

ARTHRALGIA¹,^†

# participants affected / at risk

2/61 (3.28%)

4/62 (6.45%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

BACK PAIN¹,^†

# participants affected / at risk

3/61 (4.92%)

6/62 (9.68%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

BONE PAIN¹,^†

# participants affected / at risk

0/61 (0.00%)

4/62 (6.45%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

FLANK PAIN¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

MUSCULOSKELETAL CHEST PAIN¹,^†

# participants affected / at risk

2/61 (3.28%)

2/62 (3.23%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

MUSCULOSKELETAL PAIN¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

MYALGIA¹,^†

# participants affected / at risk

10/61 (16.39%)

22/62 (35.48%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

NECK PAIN¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

PAIN IN EXTREMITY¹,^†

# participants affected / at risk

3/61 (4.92%)

3/62 (4.84%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

POLYMYALGIA RHEUMATICA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

NERVOUS SYSTEM DISORDERS

DIZZINESS¹,^†

# participants affected / at risk

11/61 (18.03%)

7/62 (11.29%)

# events

NERVOUS SYSTEM DISORDERS

HYPOAESTHESIA¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

NERVOUS SYSTEM DISORDERS

LUMBAR RADICULOPATHY¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

NERVOUS SYSTEM DISORDERS

NEUROPATHY PERIPHERAL¹,^†

# participants affected / at risk

22/61 (36.07%)

13/62 (20.97%)

# events

NERVOUS SYSTEM DISORDERS

PARAESTHESIA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

NERVOUS SYSTEM DISORDERS

PERIPHERAL SENSORY NEUROPATHY¹,^†

# participants affected / at risk

8/61 (13.11%)

10/62 (16.13%)

# events

NERVOUS SYSTEM DISORDERS

SYNCOPE¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

PSYCHIATRIC DISORDERS

ANXIETY¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

PSYCHIATRIC DISORDERS

DISORIENTATION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

PSYCHIATRIC DISORDERS

MENTAL DISORDER¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

PSYCHIATRIC DISORDERS

MOOD ALTERED¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RENAL AND URINARY DISORDERS

DYSURIA¹,^†

# participants affected / at risk

3/61 (4.92%)

5/62 (8.06%)

# events

RENAL AND URINARY DISORDERS

HAEMOGLOBINURIA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RENAL AND URINARY DISORDERS

HYDRONEPHROSIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

RENAL AND URINARY DISORDERS

MICTURITION URGENCY¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RENAL AND URINARY DISORDERS

NOCTURIA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RENAL AND URINARY DISORDERS

POLLAKIURIA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RENAL AND URINARY DISORDERS

URETHRAL PAIN¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RENAL AND URINARY DISORDERS

URINARY RETENTION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

REPRODUCTIVE SYSTEM AND BREAST DISORDERS

GENITAL RASH¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

REPRODUCTIVE SYSTEM AND BREAST DISORDERS

PELVIC DISCOMFORT¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

CHRONIC OBSTRUCTIVE PULMONARY DISEASE¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

COUGH¹,^†

# participants affected / at risk

10/61 (16.39%)

7/62 (11.29%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

DYSPHONIA¹,^†

# participants affected / at risk

0/61 (0.00%)

3/62 (4.84%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

DYSPNOEA¹,^†

# participants affected / at risk

2/61 (3.28%)

10/62 (16.13%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

DYSPNOEA EXERTIONAL¹,^†

# participants affected / at risk

0/61 (0.00%)

2/62 (3.23%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

EPISTAXIS¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

HAEMOPTYSIS¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

HICCUPS¹,^†

# participants affected / at risk

2/61 (3.28%)

4/62 (6.45%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

NASAL CONGESTION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

NASAL DISCOMFORT¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

ORGANISING PNEUMONIA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

OROPHARYNGEAL PAIN¹,^†

# participants affected / at risk

4/61 (6.56%)

3/62 (4.84%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

PRODUCTIVE COUGH¹,^†

# participants affected / at risk

0/61 (0.00%)

7/62 (11.29%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

PULMONARY EMBOLISM¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

SPUTUM INCREASED¹,^†

# participants affected / at risk

2/61 (3.28%)

2/62 (3.23%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

TONSILLAR INFLAMMATION¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

ALOPECIA¹,^†

# participants affected / at risk

30/61 (49.18%)

29/62 (46.77%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

BLISTER¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

DERMATITIS ACNEIFORM¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

HYPERHIDROSIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

NAIL DISORDER¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

ONYCHOLYSIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

PRURITUS¹,^†

# participants affected / at risk

8/61 (13.11%)

3/62 (4.84%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

RASH¹,^†

# participants affected / at risk

8/61 (13.11%)

8/62 (12.90%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

SKIN DISORDER¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

SKIN HYPERPIGMENTATION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

URTICARIA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

VASCULAR DISORDERS

HOT FLUSH¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

VASCULAR DISORDERS

HYPOTENSION¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

VASCULAR DISORDERS

PERIPHERAL COLDNESS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

VASCULAR DISORDERS

PHLEBITIS¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

VASCULAR DISORDERS

THROMBOSIS¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

GASTROINTESTINAL DISORDERS

CONSTIPATION¹,^†

# participants affected / at risk

14/61 (22.95%)

10/62 (16.13%)

# events

GASTROINTESTINAL DISORDERS

MELAENA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GASTROINTESTINAL DISORDERS

PROCTALGIA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

ASTHENIA¹,^†

# participants affected / at risk

19/61 (31.15%)

15/62 (24.19%)

# events

HEPATOBILIARY DISORDERS

HYPERBILIRUBINAEMIA¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INFECTIONS AND INFESTATIONS

BRONCHITIS¹,^†

# participants affected / at risk

1/61 (1.64%)

2/62 (3.23%)

# events

INFECTIONS AND INFESTATIONS

FURUNCLE¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INFECTIONS AND INFESTATIONS

HERPES VIRUS INFECTION¹,^†

# participants affected / at risk

1/61 (1.64%)

0/62 (0.00%)

# events

INFECTIONS AND INFESTATIONS

PARONYCHIA¹,^†

# participants affected / at risk

0/61 (0.00%)

1/62 (1.61%)

# events

INFECTIONS AND INFESTATIONS

SEPSIS¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

INVESTIGATIONS

ALANINE AMINOTRANSFERASE INCREASED¹,^†

# participants affected / at risk

4/61 (6.56%)

4/62 (6.45%)

# events

NERVOUS SYSTEM DISORDERS

DYSGEUSIA¹,^†

# participants affected / at risk

1/61 (1.64%)

1/62 (1.61%)

# events

NERVOUS SYSTEM DISORDERS

HEADACHE¹,^†

# participants affected / at risk

3/61 (4.92%)

4/62 (6.45%)

# events

PSYCHIATRIC DISORDERS

DEPRESSION¹,^†

# participants affected / at risk

1/61 (1.64%)

3/62 (4.84%)

# events

PSYCHIATRIC DISORDERS

INSOMNIA¹,^†

# participants affected / at risk

7/61 (11.48%)

4/62 (6.45%)

# events

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

RHINORRHOEA¹,^†

# participants affected / at risk

7/61 (11.48%)

0/62 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 15

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Anitra Fielding
Organization:	AstraZeneca
Phone	+44 1625 517178
E-mail:	[email protected]

Documents available

CSR_Synopsis_D0810C00039
Download
D0810C00039Protocol_and_Amendments_redacted_SECURE
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Jane Robertson

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSR_Synopsis_D0810C00039

D0810C00039Protocol_and_Amendments_redacted_SECURE

Trial Results Summaries