Assess the Efficacy of AZD8931 in Combination With Paclit... | NCT01579578

Status Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: AZD8931 Drug: Paclitaxel
2	Placebo Comparator		Drug: Placebo Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
AZD8931	Drug	40 mg, oral dose twice daily	1
Placebo

Measure	Description	Time Frame
Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone		Baseline and 8 weeks, accessed up to data cut off on 4 December 2012

Measure	Description	Time Frame
Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone	Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).	Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012

Eligibility Module

Name	Affiliation	Role
Serban Ghiorghiu, M. D.	Scarborough General Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Cologne			Germany
Research Site

Label	URL
D0102C00006\_CSR\_Synopsis	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AZD8931 40mg + Paclitaxel	AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
FG001	Placebo + Paclitaxel

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	AZD8931 40mg + Paclitaxel	AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
BG001	Placebo + Paclitaxel	AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00013 BG00112 BG00225

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00057.9± 8.71(45 to 72) BG00162.7± 13.60(34 to 76) BG00260.2± 11.34(34 to 76)

Age, Customized

Age Group

Number

Participants

Title

Denominators

Categories

18 - < 50 years

Title	Measurements
	BG0003 BG0012 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0004 BG0013 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG00013 BG00112 BG002

Race/Ethnicity, Customized

Ethnic Group Summary

Number

Participants

Title

Denominators

Categories

Asian (Other Than Chinese or Japanese)

Title	Measurements
	BG0008 BG0017 BG002

HER2 Status: HER2/IHC (Local Assessment)

HER2 Status (Local Labs): HER2/IHC (Local Assessment)

Number

Participants

Title

Denominators

Categories

HER2 0 No staining/membrane staining <10% of cells

Title	Measurements
	BG0008 BG0016 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone

Full Analysis Set

Posted

Least Squares Mean

Standard Error

percentage change

Baseline and 8 weeks, accessed up to data cut off on 4 December 2012

change from baseline

Participants

ID	Title	Description
OG000	AZD8931 + Paclitaxel	AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
OG001	Placebo + Paclitaxel	AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle

Units	Counts
Participants	OG00011 OG00111
change from baseline	OG0008 OG001

Title

Denominators

Categories

Title	Measurements
	OG000-7.7± 8.60 OG001-2.7± 8.64

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	60 patients had been considered to detect a -20% difference in the estimated average percentage change in tumour size at 8 weeks for AZD8931 plus paclitaxel compared to paclitaxel alone at a one-sided significance level of 10% with 90% power. This is based on a standard deviation of 30% for tumour data (on an absolute scale)	ANCOVA	ANCOVA model including covariates for baseline tumour size, for the time from the baseline scan to randomisation and with a term for HER2 status.	0.688	two sided p value	Mean Difference (Final Values)	-5.00	Standard Error of the Mean	12.23	2-Sided	95	-30.81	20.81			the difference in LS means is estimated

Secondary

Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone

Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).

Posted

Median

Inter-Quartile Range

months

Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012

events

Participants

ID	Title	Description
OG000	AZD8931 + Paclitaxel	AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
OG001	Placebo + Paclitaxel	AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle

Units	Counts
Participants	OG000

Secondary

The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone

The number of subjects with at least one visit response of CR or PR. (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline)

Full analysis set

Posted

Number

Participants

Baseline and 8 weeks, accessed up to data cut off on 4 December 2012

ID	Title	Description
OG000	AZD8931 + Paclitaxel	AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
OG001	Placebo + Paclitaxel	AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected13 at risk EG0010 events0 affected12 at risk
Asthenia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Peritonitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected12 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Biliary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0005 events3 affected13 at risk EG0019 events4 affected12 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0008 events6 affected13 at risk EG0019 events3 affected12 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected12 at risk
Accommodation disorder	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Blepharitis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Scleral discolouration	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Vision blurred	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected13 at risk EG0010 events0 affected12 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0012 events2 affected12 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected12 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected13 at risk EG0011 events1 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00013 events6 affected13 at risk EG0015 events5 affected12 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events3 affected13 at risk EG0012 events2 affected12 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected13 at risk EG0011 events1 affected12 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events3 affected13 at risk EG0013 events3 affected12 at risk
Asthenia	General disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected13 at risk EG0011 events1 affected12 at risk
Fatigue	General disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected13 at risk EG0015 events4 affected12 at risk
Mucosal inflammation	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected12 at risk
Oedema	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Oedema peripheral	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0014 events3 affected12 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0013 events3 affected12 at risk
Jaundice	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Bacteriuria	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Cystitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected12 at risk
Lung infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0012 events1 affected12 at risk
Oral infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Paronychia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected12 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected13 at risk EG0011 events1 affected12 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Alanine aminotransferase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected12 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected12 at risk
Blood bilirubin increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Blood creatinine increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected12 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0014 events2 affected12 at risk
Haemoglobin decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Neutrophil count decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected13 at risk EG0014 events2 affected12 at risk
Weight decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected12 at risk
White blood cell count decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0003 events1 affected13 at risk EG0013 events2 affected12 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0006 events5 affected13 at risk EG0014 events3 affected12 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected12 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0003 events1 affected13 at risk EG0010 events0 affected12 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected12 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0008 events5 affected13 at risk EG0014 events3 affected12 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected13 at risk EG0012 events2 affected12 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected12 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected13 at risk EG0012 events1 affected12 at risk
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected12 at risk
Dysgeusia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected12 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0012 events2 affected12 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected12 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected13 at risk EG0012 events2 affected12 at risk
Insomnia	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0013 events3 affected12 at risk
Haematuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected12 at risk
Proteinuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected12 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected13 at risk EG0013 events3 affected12 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0006 events5 affected13 at risk EG0012 events2 affected12 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected13 at risk EG0010 events0 affected12 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected12 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0012 events2 affected12 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0006 events5 affected13 at risk EG0010 events0 affected12 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected12 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Flushing	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected12 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0012 events2 affected12 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0017 events2 affected12 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Ascites	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0013 events2 affected12 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Gait disturbance	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Irritability	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Biliary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected12 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Platelet count decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Syncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Confusional state	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Vulval oedema	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected12 at risk
Meibomian gland dysfunction	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected12 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected12 at risk

ID	Term
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD8931 40mg + Paclitaxel	AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle			6	13	13	13
EG001	Placebo + Paclitaxel	AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle			3	12	12	12