Study Comparing Veliparib Plus Carboplatin and Paclitaxel... | NCT02264990

NCT02264990

ID	Type	Description	Link
2014-002565-30	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Veliparib + Carboplatin + Paclitaxel	Experimental	Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an area under the curve (AUC) of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles. After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.	Drug: Paclitaxel Drug: Carboplatin Drug: Veliparib Drug: Pemetrexed
Investigator's Choice Chemotherapy	Active Comparator	Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin AUC 6 mg/mLmin + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mLmin + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.	Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel	Drug	Administered by Intravenous infusion on Day 1 of each 21-day cycle	Investigator's Choice Chemotherapy Veliparib + Carboplatin + Paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup	Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.	From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup	Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first. PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.

Eligibility Module

Name	Affiliation	Role
AbbVie Inc.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clearview Cancer Institute /ID# 131434		Huntsville	Alabama	35805	United States
University of South Alabama /ID# 131518

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35331641	Derived	Govindan R, Lind M, Insa A, Khan SA, Uskov D, Tafreshi A, Guclu S, Bar J, Kato T, Lee KH, Nakagawa K, Hansen O, Biesma B, Kundu MG, Dunbar M, He L, Ansell P, Sehgal V, Huang X, Glasgow J, Bach BA. Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer. Clin Lung Cancer. 2022 May;23(3):214-225. doi: 10.1016/j.cllc.2022.01.005. Epub 2022 Feb 4.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Investigator's Choice Chemotherapy	Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin at an area under the curve (AUC) of 6 mg/mLmin + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mLmin + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 9, 2018	Feb 8, 2021

Arm/Group Information

ID	Title	Description
BG000	Investigator's Choice Chemotherapy	Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin AUC 6 mg/mLmin + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mLmin + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
BG001	Veliparib + Carboplatin + Paclitaxel	Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles. After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
BG002	Total	Total of all reporting groups

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
	OG0009.2(5.1 to 11.7) OG00111.2(7.5 to 15.8)

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		Log Rank	Log rank test stratified by ECOG performance status, investigators' preferred platinum therapy, and gender.	0.113	Statistical significance was determined by a two-sided P value ≤ 0.05.	Hazard Ratio (HR)	0.644			2-Sided	95	0.396	1.048			Hazard ratio obtained using the covariate adjusted Cox Proportional Hazard Model with covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.		Superiority

Secondary

Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup

Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first.

PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.

Participants in the ITT population who were LSP positive

Posted

Median

95% Confidence Interval

months

From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

ID	Title	Description
OG000	Investigator's Choice Chemotherapy	Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin AUC 6 mg/mLmin + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mLmin + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Secondary

Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup

Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.

CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.

Participants in the ITT population who were LSP positive

Posted

Number

95% Confidence Interval

percentage of participants

Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.

ID	Title	Description
OG000	Investigator's Choice Chemotherapy	Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin AUC 6 mg/mLmin + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mLmin + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Secondary

Overall Survival in All Participants

Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.

Participants in the ITT population

Posted

Median

95% Confidence Interval

months

From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

ID	Title	Description
OG000	Investigator's Choice Chemotherapy	Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin AUC 6 mg/mLmin + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mLmin + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
OG001	Veliparib + Carboplatin + Paclitaxel	Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles. After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Secondary

Progression Free Survival (PFS) in All Participants

Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first.

PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.

Participants in the ITT population

Posted

Median

95% Confidence Interval

months

From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

ID	Title	Description
OG000	Investigator's Choice Chemotherapy	Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin AUC 6 mg/mLmin + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mLmin + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Secondary

Objective Response Rate (ORR) in All Participants

Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.

CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Participants in the ITT population

Posted

Number

95% Confidence Interval

percentage of participants

ID	Title	Description
OG000	Investigator's Choice Chemotherapy	Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin AUC 6 mg/mLmin + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mLmin + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Investigator's Choice Chemotherapy	Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin AUC 6 mg/mLmin + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mLmin + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.	255	297	98	288	269	288
EG001	Veliparib + Carboplatin + Paclitaxel	Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles. After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.	250	298	121	293	275	293

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00017 events15 affected288 at risk EG0018 events7 affected293 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00010 events7 affected288 at risk EG00115 events13 affected293 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected293 at risk
LYMPHADENITIS	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected288 at risk EG0019 events6 affected293 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected288 at risk EG0012 events2 affected293 at risk
ARTERIOSPASM CORONARY	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0014 events4 affected293 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected293 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0012 events2 affected293 at risk
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0017 events7 affected293 at risk
PERICARDITIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected293 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected288 at risk EG0012 events2 affected293 at risk
APHTHOUS ULCER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
ASCITES	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
COLITIS ULCERATIVE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0012 events2 affected293 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events2 affected293 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
MESENTERIC VEIN THROMBOSIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected288 at risk EG0013 events3 affected293 at risk
OESOPHAGEAL STENOSIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
VOMITING	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected288 at risk EG0016 events6 affected293 at risk
ASTHENIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events1 affected293 at risk
CATHETER SITE HAEMORRHAGE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
CHEST PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
DISEASE PROGRESSION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
FATIGUE	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected293 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected293 at risk
MALAISE	General disorders	MedDRA 21.0	Systematic Assessment	EG0006 events3 affected288 at risk EG0010 events0 affected293 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected293 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected293 at risk
PERIPHERAL SWELLING	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PYREXIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
SUDDEN DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0012 events2 affected293 at risk
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
ANAPHYLACTIC SHOCK	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0014 events3 affected293 at risk
ABDOMINAL ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
APPENDICITIS PERFORATED	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
BRONCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
DIARRHOEA INFECTIOUS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
EMPYEMA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected293 at risk
INFLUENZA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected293 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0014 events4 affected293 at risk
LUNG INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected293 at risk
LYMPHANGITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PERITONSILLAR ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected293 at risk
PNEUMONIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected288 at risk EG00126 events19 affected293 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PNEUMONIA PSEUDOMONAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PSEUDOMONAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PULMONARY SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected288 at risk EG0011 events1 affected293 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0012 events2 affected293 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events1 affected293 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events2 affected293 at risk
VASCULAR DEVICE INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
HEART INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events1 affected293 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
RADIATION OESOPHAGITIS	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0012 events2 affected293 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected288 at risk EG0010 events0 affected293 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0011 events1 affected293 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0013 events3 affected293 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected288 at risk EG0011 events1 affected293 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
CANCER PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
MALIGNANT NEOPLASM PROGRESSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG00012 events10 affected288 at risk EG00119 events14 affected293 at risk
MALIGNANT PLEURAL EFFUSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0014 events4 affected293 at risk
METASTASES TO MENINGES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
PERICARDIAL EFFUSION MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected293 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events1 affected293 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
DELIRIUM	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events2 affected293 at risk
DEPRESSION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
DISORIENTATION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected293 at risk
AZOTAEMIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected288 at risk EG0012 events2 affected293 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0012 events2 affected293 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 events7 affected288 at risk EG0018 events8 affected293 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected288 at risk EG0011 events1 affected293 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
ORGANISING PNEUMONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 events6 affected288 at risk EG0017 events5 affected293 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected288 at risk EG0015 events5 affected293 at risk
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected293 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected288 at risk EG0012 events2 affected293 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
SUBCUTANEOUS EMPHYSEMA	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
ANEURYSM	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
AXILLARY VEIN THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected293 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected293 at risk
HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0012 events2 affected293 at risk
HYPOVOLAEMIC SHOCK	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected293 at risk
VENOUS THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected293 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000197 events107 affected288 at risk EG001212 events112 affected293 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00077 events40 affected288 at risk EG00177 events43 affected293 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000175 events89 affected288 at risk EG001210 events104 affected293 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000102 events54 affected288 at risk EG001155 events76 affected293 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000113 events92 affected288 at risk EG00181 events69 affected293 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00060 events47 affected288 at risk EG00170 events51 affected293 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000202 events131 affected288 at risk EG001121 events86 affected293 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00032 events30 affected288 at risk EG00124 events19 affected293 at risk
VOMITING	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00099 events73 affected288 at risk EG00148 events39 affected293 at risk
ASTHENIA	General disorders	MedDRA 21.0	Systematic Assessment	EG00050 events30 affected288 at risk EG00158 events29 affected293 at risk
FATIGUE	General disorders	MedDRA 21.0	Systematic Assessment	EG000117 events89 affected288 at risk EG001108 events80 affected293 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 21.0	Systematic Assessment	EG00036 events24 affected288 at risk EG00116 events13 affected293 at risk
PYREXIA	General disorders	MedDRA 21.0	Systematic Assessment	EG00021 events16 affected288 at risk EG00117 events15 affected293 at risk
WEIGHT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG00025 events24 affected288 at risk EG00117 events14 affected293 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG000109 events79 affected288 at risk EG00179 events63 affected293 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00015 events11 affected288 at risk EG00124 events24 affected293 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00019 events16 affected288 at risk EG00122 events21 affected293 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00014 events12 affected288 at risk EG00118 events16 affected293 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00035 events26 affected288 at risk EG00145 events39 affected293 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00024 events22 affected288 at risk EG00121 events17 affected293 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00013 events9 affected288 at risk EG00121 events15 affected293 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00022 events17 affected288 at risk EG00150 events38 affected293 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00019 events15 affected288 at risk EG00117 events15 affected293 at risk
DIZZINESS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00025 events22 affected288 at risk EG00117 events17 affected293 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00033 events29 affected288 at risk EG00120 events19 affected293 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00051 events42 affected288 at risk EG001195 events131 affected293 at risk
INSOMNIA	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00030 events30 affected288 at risk EG00139 events37 affected293 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00031 events29 affected288 at risk EG00132 events27 affected293 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00030 events25 affected288 at risk EG00146 events42 affected293 at risk
HICCUPS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00029 events21 affected288 at risk EG00127 events17 affected293 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00016 events15 affected288 at risk EG0018 events6 affected293 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00040 events34 affected288 at risk EG001160 events137 affected293 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00029 events25 affected288 at risk EG00116 events13 affected293 at risk

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic

A fixed sequence testing procedure was used for analyses of the primary and secondary efficacy endpoints to control for the familywise error rate. If veliparib plus C/P treatment was not statistically significantly better compared to the investigators' choice of standard therapy for the primary efficacy endpoint of OS in LSP+ participants, then statistical significance would not be declared for any of the secondary efficacy endpoints.

ID	Term
D009362	Neoplasm Metastasis
D002289	Carcinoma, Non-Small-Cell Lung

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D017239	Paclitaxel
D016190	Carboplatin
D002945	Cisplatin
C521013	veliparib
D000068437	Pemetrexed