Dose Escalation and Double-blind Study of Veliparib in Co... | NCT02289690

ID	Type	Description	Link
2014-001764-35	EudraCT Number

Description Module

Detailed Description

This is a Phase 1, open-label, dose-escalation/Phase 2 randomized double-blind study of veliparib in combination with carboplatin and etoposide and maintenance veliparib monotherapy.

Participants in Phase 1 will be sequentially assigned to ascending dose levels of veliparib in combination with standard carboplatin/etoposide regimen for up to four 21-day cycles based on the observed toxicities. The study design for Phase 1 will follow a traditional "3 + 3" dose-escalation protocol.

Once the veliparib recommended Phase 2 dose (RPTD) and schedule is determined, enrollment into Phase 2 will begin. Participants from the Phase 1 dose-escalation portion of the study are not eligible for enrollment into the Phase 2 portion. Participants in Phase 2 will be randomized in a 1:1:1 ratio to carboplatin, etoposide, placebo followed by placebo maintenance (Arm C), or carboplatin, etoposide, veliparib followed by either veliparib (Arm A) or placebo (Arm B) maintenance. Randomization for Phase 2 will be stratified by baseline lactate dehydrogenase (LDH) level (> upper limit of normal [ULN] vs. ≤ ULN), and gender.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase 1: Veliparib + Carboplatin + Etoposide	Experimental	Participants in Phase 1 will be sequentially assigned to ascending dose levels of veliparib in combination with carboplatin/etoposide for up to four 21-day cycles. Participants without evidence of disease progression will continue on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Drug: Veliparib Drug: Carboplatin Drug: Etoposide
Phase 2: Veliparib + Carboplatin + Etoposide -> Veliparib	Experimental	Participants will receive veliparib 240 mg in combination with carboplatin/etoposide for four to six 21-day cycles followed by veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Drug: Veliparib Drug: Carboplatin Drug: Etoposide
Phase 2: Veliparib + Carboplatin + Etoposide -> Placebo	Experimental	Participants will receive veliparib 240 mg in combination with carboplatin/etoposide for four to six 21-day cycles followed by placebo monotherapy continuous dosing (21-day cycles) until disease progression or unacceptable toxicity occurs.	Drug: Veliparib Drug: Carboplatin Drug: Etoposide Drug: Placebo
Phase 2: Placebo + Carboplatin + Etoposide -> Placebo	Active Comparator	Participants will receive placebo in combination with carboplatin/etoposide for four to six 21-day cycles followed by placebo monotherapy continuous dosing (21-day cycles) until disease progression or unacceptable toxicity occurs.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Veliparib	Drug	Capsules administered orally twice a day according to the dosing schedule.	Phase 1: Veliparib + Carboplatin + Etoposide Phase 2: Veliparib + Carboplatin + Etoposide -> Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)	A DLT was defined as any of the following drug-related toxicities, graded according to the Common Toxicity Criteria for Adverse Events (CTCAE), V.4.0: Events associated with treatment delay >14 days in initiating Cycle 2 therapy: Grade 4 thrombocytopenia, neutropenia, or febrile neutropenia, or Grade 3 febrile neutropenia with fever for > 7 days Grade ≥ 3 non-hematologic toxicity with ≥ 2 grade increase from baseline and attributed to veliparib treatment, excluding nausea or vomiting for ≤ 48 hours or inadequately treated, electrolyte abnormalities resolving in ≤ 24 hours, hypersensitivity reactions or alopecia Grade 2 non-hematologic toxicity of ≥ 2 grade increase from baseline, attributed to veliparib treatment requiring delay of >14 days in initiation of Cycle 2 Any toxicity of ≥ 2-grade increase from baseline, attributed to veliparib and requiring a dose modification in Cycle 1 or omission of carboplatin, >1 daily etoposide dose, or >30% veliparib doses in Cycle 1	Cycle 1 Day -2 to pre-dose on Cycle 2 Day 1 (23 days)
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Veliparib	Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.	Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Veliparib	Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.	Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose
Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose (AUC[0-8]) of Veliparib

Secondary Outcomes

Measure	Description	Time Frame
Phase 2: Overall Survival	Overall survival (OS) is defined as the time from the date of randomization to the date of death. If a participant did not die on or prior to the cut-off for OS analysis, the participant's data were censored at the date of their last known alive date, which is defined as the last date of the last survival follow-up visit, the start date of the last AE, the start date or end date of the last dose of any study drugs, the last lab and vital sign collection date, or the last disease assessment date, whichever occurred last.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject with histologically or cytologically confirmed extensive-stage disease SCLC which is newly diagnosed and chemotherapy naive
Phase 1 ONLY: histologically or cytologically confirmed advanced/metastatic solid tumors for which carboplatin/etoposide treatment is considered appropriate.
Subject in Phase 2 only: must have measurable disease per RECIST 1.1.
Subjects with ED SCLC must consent to provide available archived formalin fixed paraffin embedded (FFPE) tissue sample of SCLC lesion (primary or metastatic) for central review and biomarker analysis.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
Subject must have adequate hematologic, renal and hepatic function.

Exclusion Criteria:

Phase 1 ONLY: Subject has had any prior anti-cancer therapy other than:

Hormonal, non-myelosuppressive, biologic, targeted, or immune therapy (must be completed ≥ 4 weeks prior to Cycle 1 Day -2).

One line of cytotoxic chemotherapy (must be completed ≥ 4 weeks prior to Cycle 1 Day -2).

Adjuvant/neoadjuvant radiotherapy (must be completed ≥ 12 months prior to Cycle 1 Day -2, with field not involving > 10% of bone marrow reserve).
Phase 2 ONLY: Subject has had any prior chemotherapy, radiotherapy, investigational anti-cancer agents or biologic therapy for the disease under study. Single non-target lesion irradiation with intent of symptom palliation is allowed if ≥ 4 weeks prior Cycle 1 Day -2.
Subject has current central nervous system (CNS) or leptomeningeal metastases or history of CNS or leptomeningeal metastases.
Subject has a history of seizures within 12 months of Cycle 1 Day-2 or diagnosed neurological condition placing subject at the increased risk of seizures.
Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day-2.
Subject has had major surgery within 6 weeks prior to Cycle 1 Day-2 (subjects must have completely recovered from any previous surgery prior Cycle 1 Day-2).
Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
- Uncontrolled nausea/vomiting/diarrhea;
- Active uncontrolled infection;
- History of hepatitis B (HBV) with surface antigen (HBsAg) positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months, it must be done at screening);
- History of hepatitis C (HCV) with HCV ribonucleic acid (RNA) positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months it must be done at screening);
- Symptomatic congestive heart failure (Yew York Heart Association [NYHA] class ≥ II);
- Unstable angina pectoris or cardiac arrhythmia (except atrial fibrillation);
- Psychiatric illness/social situation that would limit compliance with study requirements;
- Any other medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities.
The subject has a history of another active cancer within the past 3 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous or basal cell carcinoma of the skin or another in situ cancer that is considered cured by the investigator (e.g., in situ prostate cancer, breast DCIS).

Name	Affiliation	Role
AbbVie Inc.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic - Scottsdale /ID# 129127		Scottsdale	Arizona	85259	United States
Univ of Colorado Cancer Center /ID# 129220

PubMed Identifier	Type	Citation	Retractions
30327308	Result	Atrafi F, Groen HJM, Byers LA, Garralda E, Lolkema MP, Sangha RS, Viteri S, Chae YK, Camidge DR, Gabrail NY, Hu B, Tian T, Nuthalapati S, Hoening E, He L, Komarnitsky P, Calles A. A Phase I Dose-Escalation Study of Veliparib Combined with Carboplatin and Etoposide in Patients with Extensive-Stage Small Cell Lung Cancer and Other Solid Tumors. Clin Cancer Res. 2019 Jan 15;25(2):496-505. doi: 10.1158/1078-0432.CCR-18-2014. Epub 2018 Oct 16.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.

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	Nov 24, 2016	Apr 14, 2020

Arm/Group Information

ID	Title	Description
BG000	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide	Participants received 80 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG001	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG002	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide	Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease pParticipants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG003	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide	Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG004	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide	Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG005	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide	Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG006	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide	Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG007	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib	Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG008	Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo	Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG009	Phase 2: Placebo + Carboplatin/Etoposide -> Placebo	Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
BG010	Total	Total of all reporting groups

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

Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)

A DLT was defined as any of the following drug-related toxicities, graded according to the Common Toxicity Criteria for Adverse Events (CTCAE), V.4.0:

Events associated with treatment delay >14 days in initiating Cycle 2 therapy:

Grade 4 thrombocytopenia, neutropenia, or febrile neutropenia, or Grade 3 febrile neutropenia with fever for > 7 days
Grade ≥ 3 non-hematologic toxicity with ≥ 2 grade increase from baseline and attributed to veliparib treatment, excluding nausea or vomiting for ≤ 48 hours or inadequately treated, electrolyte abnormalities resolving in ≤ 24 hours, hypersensitivity reactions or alopecia
Grade 2 non-hematologic toxicity of ≥ 2 grade increase from baseline, attributed to veliparib treatment requiring delay of >14 days in initiation of Cycle 2
Any toxicity of ≥ 2-grade increase from baseline, attributed to veliparib and requiring a dose modification in Cycle 1 or omission of carboplatin, >1 daily etoposide dose, or >30% veliparib doses in Cycle 1

Phase 1 participants who received at least 1 dose of study drug

Posted

Count of Participants

Participants

Cycle 1 Day -2 to pre-dose on Cycle 2 Day 1 (23 days)

ID	Title	Description
OG000	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
OG001	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
OG002	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide	Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
OG003	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide

Units	Counts
Participants	OG0004 OG0013 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

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 OG002 OG003 OG004 OG005 OG006	A primary objective of Phase 1 was to establish the recommended phase 2 dose (RP2D) for veliparib combined with carboplatin and etoposide. The RP2D was determined by the rate of DLTs and overall tolerability of veliparib plus carboplatin and etoposide.					RP2D for veliparib in mg BID for 14 days	240			2-Sided						The RP2D for veliparib was determined to be 240 mg BID for 14 days with carboplatin (AUC 5 mg/mL*min) on Day 1 and etoposide (100 mg/m²) on Days 1 to 3 during 21-day cycles for 4 cycles.

Primary

Phase 1: Maximum Observed Plasma Concentration (Cmax) of Veliparib

Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.

Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom Cmax could be calculated.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

ID	Title	Description
OG000	Phase 1: Veliparib 80 mg BID + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
OG001	Phase 1: Veliparib 120 mg BID + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.

Primary

Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Veliparib

Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom Tmax could be calculated.

Posted

Median

Full Range

hours

Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

ID	Title	Description
OG000	Phase 1: Veliparib 80 mg BID + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
OG001	Phase 1: Veliparib 120 mg BID + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.

Primary

Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose (AUC[0-8]) of Veliparib

The area under the plasma concentration-time curve from time 0 to 8 hours post-dose for veliparib was estimated using non-compartmental methods.

Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom AUC(0-8) could be calculated.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg*h/mL

Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

ID	Title	Description
OG000	Phase 1: Veliparib 80 mg BID + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
OG001	Phase 1: Veliparib 120 mg BID + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
OG002

Primary

Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC[0-12]) of Veliparib

The area under the plasma concentration-time curve from time 0 to 12 hours post-dose for veliparib was estimated using non-compartmental methods. AUC(0-12) was calculated by assuming the concentration at 12 hours post-dose was the same as the pre-dose concentration.

Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom AUC(0-12) could be calculated.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg*h/mL

Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

ID	Title	Description
OG000	Phase 1: Veliparib 80 mg BID + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
OG001	Phase 1: Veliparib 120 mg BID + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.

Primary

Phase 1: Dose-normalized Maximum Observed Plasma Concentration of Veliparib

Dose normalized Cmax is calculated as Cmax / veliparib dose in mg.

Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom Cmax could be calculated.

Posted

Geometric Mean

Geometric Coefficient of Variation

(ng/mL)/mg

Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

ID	Title	Description
OG000	Phase 1: Veliparib 80 mg BID + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
OG001	Phase 1: Veliparib 120 mg BID + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.

Primary

Phase 1: Dose-normalized Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose of Veliparib

The area under the plasma concentration-time curve from time 0 to 8 hours post-dose for veliparib was estimated using non-compartmental methods. Dose normalized AUC(0-8) is calculated as AUC(0-8) / veliparib dose in mg.

Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom AUC(0-8) could be calculated.

Posted

Geometric Mean

Geometric Coefficient of Variation

(ng*h/mL)/mg

Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

ID	Title	Description
OG000	Phase 1: Veliparib 80 mg BID + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
OG001	Phase 1: Veliparib 120 mg BID + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.

Primary

Phase 1: Dose-normalized Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose of Veliparib

Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom AUC(0-12) could be calculated.

Posted

Geometric Mean

Geometric Coefficient of Variation

(ng*h/mL)/mg

Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

ID	Title	Description
OG000	Phase 1: Veliparib 80 mg BID + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.
OG001	Phase 1: Veliparib 120 mg BID + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle.

Primary

Phase 1: Maximum Observed Plasma Concentration (Cmax) of Etoposide With and Without Veliparib

Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL.

Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom Cmax could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group and participants whose etoposide dose was reduced in Cycle 2 are not included in the Cycle 2 Day 1 analysis.

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Geometric Mean

Geometric Coefficient of Variation

μg/mL

Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

ID	Title	Description
OG000	Etoposide Cycle 1 Day 1 (With Veliparib)	Phase 1 participants received 100 mg/m² etoposide intravenously with carboplatin target AUC 5.0 mg*min/mL and veliparib 80 to 240 mg BID on Cycle 1 Day 1.
OG001	Etoposide Cycle 2 Day 1 (No Veliparib)	Phase 1 participants received etoposide 100 mg/m² and carboplatin target AUC 5.0 mg*min/mL on Day 1 of Cycle 2. No veliparib was administered.

Primary

Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Etoposide With and Without Veliparib

Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL.

Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom Tmax could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group are not included in the Cycle 2 Day 1 analysis.

Posted

Median

Full Range

hours

ID	Title	Description
OG000	Etoposide Cycle 1 Day 1 (With Veliparib)	Phase 1 participants received 100 mg/m² etoposide intravenously with carboplatin target AUC 5.0 mg*min/mL and veliparib 80 to 240 mg BID on Cycle 1 Day 1.
OG001	Etoposide Cycle 2 Day 1 (No Veliparib)	Phase 1 participants received etoposide 100 mg/m² and carboplatin target AUC 5.0 mg*min/mL on Day 1 of Cycle 2. No veliparib was administered.

Primary

Phase 1: Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC[0-t]) of Etoposide With and Without Veliparib

The area under the plasma concentration-time curve from 0 to the last measurable concentration (24 hours) of etoposide was estimated using using non-compartmental methods.

Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom AUC could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group and participants whose etoposide dose was reduced in Cycle 2 are not included in the Cycle 2 Day 1 analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg*h/mL

ID	Title	Description
OG000	Etoposide Cycle 1 Day 1 (With Veliparib)	Phase 1 participants received 100 mg/m² etoposide intravenously with carboplatin target AUC 5.0 mg*min/mL and veliparib 80 to 240 mg BID on Cycle 1 Day 1.
OG001	Etoposide Cycle 2 Day 1 (No Veliparib)	Phase 1 participants received etoposide 100 mg/m² and carboplatin target AUC 5.0 mg*min/mL on Day 1 of Cycle 2. No veliparib was administered.

Primary

Phase 1: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) of Etoposide With and Without Veliparib

The area under the plasma concentration-time curve from 0 to infinity for etoposide was estimated using using non-compartmental methods.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg*h/mL

ID	Title	Description
OG000	Etoposide Cycle 1 Day 1 (With Veliparib)	Phase 1 participants received 100 mg/m² etoposide intravenously with carboplatin target AUC 5.0 mg*min/mL and veliparib 80 to 240 mg BID on Cycle 1 Day 1.
OG001	Etoposide Cycle 2 Day 1 (No Veliparib)	Phase 1 participants received etoposide 100 mg/m² and carboplatin target AUC 5.0 mg*min/mL on Day 1 of Cycle 2. No veliparib was administered.

Primary

Phase 1: Terminal Phase Elimination Half-life (t1/2) of Etoposide With and Without Veliparib

The terminal half-life of etoposide was estimated using using non-compartmental methods. Values reported represent the harmonic mean ± pseudo-standard deviation.

Participants in Phase 1 who received at least 1 dose of study drug and had at least 1 reported PK sample concentration for each time point and for whom t1/2 could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group are not included in the Cycle 2 Day 1 analysis.

Posted

Mean

Standard Deviation

hours

ID	Title	Description
OG000	Etoposide Cycle 1 Day 1 (With Veliparib)	Phase 1 participants received 100 mg/m² etoposide intravenously with carboplatin target AUC 5.0 mg*min/mL and veliparib 80 to 240 mg BID on Cycle 1 Day 1.
OG001	Etoposide Cycle 2 Day 1 (No Veliparib)	Phase 1 participants received etoposide 100 mg/m² and carboplatin target AUC 5.0 mg*min/mL on Day 1 of Cycle 2. No veliparib was administered.

Primary

Phase 1: Dose-normalized Maximum Observed Plasma Concentration (Cmax) of Etoposide With and Without Veliparib

Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL. Dose normalized Cmax is calculated as Cmax / etoposide dose in mg/m².

Posted

Geometric Mean

Geometric Coefficient of Variation

(ng/mL)/(mg/m²)

ID	Title	Description
OG000	Etoposide Cycle 1 Day 1 (With Veliparib)	Phase 1 participants received 100 mg/m² etoposide intravenously with carboplatin target AUC 5.0 mg*min/mL and veliparib 80 to 240 mg BID on Cycle 1 Day 1.
OG001	Etoposide Cycle 2 Day 1 (No Veliparib)	Phase 1 participants received etoposide 100 mg/m² and carboplatin target AUC 5.0 mg*min/mL on Day 1 of Cycle 2. No veliparib was administered.

Primary

Phase 1: Dose-normalized Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC[0-t]) of Etoposide With and Without Veliparib

The area under the plasma concentration-time curve from 0 to the last measurable concentration (24 hours) of etoposide was estimated using using non-compartmental methods. Dose normalized AUC(0-t) is calculated as AUC(0-t) / etoposide dose in mg/m².

Posted

Geometric Mean

Geometric Coefficient of Variation

(ng*h/mL)/(mg/m²)

ID	Title	Description
OG000	Etoposide Cycle 1 Day 1 (With Veliparib)	Phase 1 participants received 100 mg/m² etoposide intravenously with carboplatin target AUC 5.0 mg*min/mL and veliparib 80 to 240 mg BID on Cycle 1 Day 1.
OG001	Etoposide Cycle 2 Day 1 (No Veliparib)	Phase 1 participants received etoposide 100 mg/m² and carboplatin target AUC 5.0 mg*min/mL on Day 1 of Cycle 2. No veliparib was administered.

Primary

Phase 1: Dose-normalized Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) of Etoposide With and Without Veliparib

The area under the plasma concentration-time curve from 0 to infinity for etoposide was estimated using using non-compartmental methods. Dose normalized AUC(0-∞) is calculated as AUC(0-∞) / etoposide dose in mg/m².

Posted

Geometric Mean

Geometric Coefficient of Variation

(ng*h/mL)/(mg/m²)

ID	Title	Description
OG000	Etoposide Cycle 1 Day 1 (With Veliparib)	Phase 1 participants received 100 mg/m² etoposide intravenously with carboplatin target AUC 5.0 mg*min/mL and veliparib 80 to 240 mg BID on Cycle 1 Day 1.
OG001	Etoposide Cycle 2 Day 1 (No Veliparib)	Phase 1 participants received etoposide 100 mg/m² and carboplatin target AUC 5.0 mg*min/mL on Day 1 of Cycle 2. No veliparib was administered.

Primary

Phase 2: Progression-free Survival

Progression-free survival (PFS) is defined as the time from the date of randomization to the date of earliest radiographic disease progression or death provided no radiographic disease progression occurred.

If a participant did not have an event of disease progression and had not died on or prior to the cutoff for PFS analysis, the participant's data was censored at the date of their last disease assessment or randomization date provided participant did not have any post-baseline disease assessment.

Disease assessments were performed using computed tomography according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions.

All participants randomized in Phase 2

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Median

80% Confidence Interval

months

From randomization up to the date the 126th PFS event was reached; Median time on follow-up was 7.3, 7.1, and 8.9 months in each treatment group respectively.

ID	Title	Description
OG000	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib	Participants in Arm A received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.

Secondary

Phase 2: Overall Survival

Overall survival (OS) is defined as the time from the date of randomization to the date of death. If a participant did not die on or prior to the cut-off for OS analysis, the participant's data were censored at the date of their last known alive date, which is defined as the last date of the last survival follow-up visit, the start date of the last AE, the start date or end date of the last dose of any study drugs, the last lab and vital sign collection date, or the last disease assessment date, whichever occurred last.

All participants randomized in Phase 2

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Median

80% Confidence Interval

months

From randomization until the end of study; median time on follow-up was 10.0, 8.6, and 11.7 months in each treatment group respectively.

ID	Title	Description
OG000	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib	Participants in Arm A received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
OG001	Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo	Participants in Arm B received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.

Secondary

Phase 2: Objective Response Rate

Objective response rate (ORR) is defined as the percentage of participants with objective response (confirmed) as assessed by the investigator using RECIST version 1.1. Objective response includes both complete response (CR) and partial response (PR). Response must be confirmed at a subsequent tumor assessment at least 28 days apart. Participants with no post-baseline confirmed response were counted as non-responders.

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

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and no new lesions.

All participants randomized in Phase 2

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Number

80% Confidence Interval

percentage of participants

Tumor assessments were performed every 6 weeks for the first 30 weeks and every 9 weeks thereafter until disease progression; median time on follow-up was 7.3, 7.1, and 8.9 months in each group respectively.

ID	Title	Description
OG000	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib	Participants in Arm A received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
OG001

Secondary

Phase 1: Number of Participants With Adverse Events

The intensity of each adverse event (AE) was assessed utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0, and according to the following: Grade 1 (Mild): AE is transient and easily tolerated by the participant; Grade 2 (Moderate): AE causes the participant discomfort and interrupts the participant's usual activities; Grade 3/4 (Severe): The adverse event causes considerable interference with the participant's usual activities and may be incapacitating or life-threatening; Grade 5: Death.

Serious adverse events were those that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in congenital anomaly, or persistent or significant disability/incapacity.

Participants in Phase 1 who received at least 1 dose of study drug.

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Count of Participants

Participants

From first dose of any study drug to 30 days after the last dose; the median duration of treatment with veliparib across all groups in Phase 1 was 127.5 days.

ID	Title	Description
OG000	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide	Participants received 80 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg twice a day until disease progression or unacceptable toxicity.

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	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide	Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	0	4	3	4	4	4
EG001	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide	Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	0	3	1	3	3	3
EG002	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide	Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	1	4	3	4	4	4
EG003	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide	Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	1	3	2	3	3	3
EG004	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide	Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	0	8	3	8	8	8
EG005	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide	Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	0	14	6	14	14	14
EG006	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide	Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	0	4	3	4	4	4
EG007	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib	Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	50	61	33	60	57	60
EG008	Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo	Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	45	59	39	58	53	58
EG009	Phase 2: Placebo + Carboplatin/Etoposide -> Placebo	Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	41	61	27	60	53	60

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG0030 events0 affected3 at risk EG0040 events0 affected8 at risk EG0050 events0 affected14 at risk EG0060 events0 affected4 at risk EG0073 events3 affected60 at risk EG0083 events3 affected58 at risk EG0093 events2 affected60 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
SINUS NODE DYSFUNCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DIABETES INSIPIDUS	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
COLITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DUODENAL ULCER PERFORATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
GASTRIC PERFORATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
GASTROINTESTINAL INFLAMMATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ILEUS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0022 events1 affected4 at risk EG003
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MOUTH HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PALATAL OEDEMA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ASTHENIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CHEST PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DISEASE PROGRESSION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
FATIGUE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MALAISE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0022 events1 affected4 at risk EG003
PYREXIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
SUDDEN CARDIAC DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
SUDDEN DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ABDOMINAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ANAL ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DEVICE RELATED INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ENCEPHALITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
IMPLANT SITE CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ORCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PLEURAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
PNEUMONIA INFLUENZAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PNEUMONIA LEGIONELLA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
VASCULAR PROCEDURE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PLATELET COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
TRANSAMINASES INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CANCER PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MALIGNANT NEOPLASM PROGRESSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MIGRAINE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MOTOR DYSFUNCTION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
TOXIC NEUROPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
AORTITIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HAEMORRHAGE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PERIPHERAL ARTERY THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PERIPHERAL EMBOLISM	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
SUPERIOR VENA CAVA SYNDROME	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
VENA CAVA THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected4 at risk EG0011 events1 affected3 at risk EG0029 events2 affected4 at risk EG0033 events1 affected3 at risk EG00411 events4 affected8 at risk EG00518 events7 affected14 at risk EG0066 events2 affected4 at risk EG007104 events35 affected60 at risk EG008105 events35 affected58 at risk EG00955 events26 affected60 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events1 affected4 at risk EG0010 events0 affected3 at risk EG0028 events2 affected4 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4 at risk EG0012 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PALPITATIONS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
EAR DISCOMFORT	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0022 events1 affected4 at risk EG003
HYPOACUSIS	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
OTOTOXICITY	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
TINNITUS	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
BLINDNESS	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DRY EYE	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
EYE IRRITATION	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
EYE PAIN	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
LACRIMATION INCREASED	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
VITREOUS DETACHMENT	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0023 events2 affected4 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
ANAL INFLAMMATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ASCITES	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0011 events1 affected3 at risk EG0021 events1 affected4 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected3 at risk EG0024 events2 affected4 at risk EG003
DIVERTICULUM	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ENTEROVESICAL FISTULA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ERUCTATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0014 events2 affected3 at risk EG0027 events2 affected4 at risk EG003
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ORAL DISCOMFORT	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PROCTALGIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PROCTITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
RETCHING	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
STOMATITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0012 events2 affected3 at risk EG0024 events3 affected4 at risk EG003
ASTHENIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
CHEST PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CREPITATIONS	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CRYING	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
FACE OEDEMA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
FATIGUE	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4 at risk EG0015 events3 affected3 at risk EG0022 events1 affected4 at risk EG003
FEELING ABNORMAL	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
FEELING COLD	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
GAIT DISTURBANCE	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0024 events1 affected4 at risk EG003
INJECTION SITE EXTRAVASATION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
INJECTION SITE HAEMATOMA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
INJECTION SITE PHLEBITIS	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
LOSS OF CONTROL OF LEGS	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MALAISE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MUCOSAL INFLAMMATION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
NECROSIS	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
OEDEMA	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PYREXIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
SWELLING	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
SWELLING FACE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
HEPATIC PAIN	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CYSTITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DEVICE RELATED INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0021 events1 affected4 at risk EG003
ORAL CANDIDIASIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ORAL FUNGAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
RHINITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0022 events1 affected4 at risk EG003
TOOTH ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected3 at risk EG0022 events1 affected4 at risk EG003
CHEMICAL PHLEBITIS	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
FOREARM FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MUSCLE RUPTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
POST PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PROCEDURAL HEADACHE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
SKIN ABRASION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HLA MARKER STUDY POSITIVE	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
LYMPHOCYTE COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0015 events1 affected3 at risk EG0021 events1 affected4 at risk EG003
PLATELET COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
TRANSAMINASES INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
URINE OUTPUT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
WEIGHT INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0023 events2 affected4 at risk EG003
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected4 at risk EG0014 events2 affected3 at risk EG0023 events3 affected4 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
COCCYDYNIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
GROIN PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected3 at risk EG0022 events2 affected4 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected4 at risk EG0012 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
MYOSITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0012 events2 affected3 at risk EG0022 events2 affected4 at risk EG003
PAIN IN JAW	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
SPINAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
TENDON PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CANCER PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MALIGNANT NEOPLASM PROGRESSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
ATAXIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
DISTURBANCE IN ATTENTION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
DYSARTHRIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DYSGEUSIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
HEAD DISCOMFORT	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
MUSCLE CONTRACTIONS INVOLUNTARY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
PERIPHERAL MOTOR NEUROPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0012 events2 affected3 at risk EG0021 events1 affected4 at risk EG003
POLYNEUROPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
PRESYNCOPE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
SOMNOLENCE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
TREMOR	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DEVICE OCCLUSION	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DELIRIUM	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0021 events1 affected4 at risk EG003
HALLUCINATION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
RESTLESSNESS	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
TENSION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DYSURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
NOCTURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
PNEUMATURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
POST MICTURITION DRIBBLE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
TUBULOINTERSTITIAL NEPHRITIS	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
URINARY HESITATION	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PERINEAL PAIN	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0022 events2 affected4 at risk EG003
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected4 at risk EG0011 events1 affected3 at risk EG0022 events1 affected4 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HICCUPS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0021 events1 affected4 at risk EG003
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected4 at risk EG0011 events1 affected3 at risk EG0023 events2 affected4 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
ECCHYMOSIS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
PIGMENTATION DISORDER	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003
STICKY SKIN	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HAEMATOMA	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HOT FLUSH	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected3 at risk EG0020 events0 affected4 at risk EG003
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected3 at risk EG0021 events1 affected4 at risk EG003

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates