Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01506609
• Collaborator: (none)
• Enrollment: 294
• Locations: 120
• Arms: 3
• Actual Duration (Months): 103.3
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Placebo; Drug: Veliparib; Drug: Carboplatin; Drug: Temozolomide; Drug: Paclitaxel	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 294 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
• Actual Study Start Date: Jan 23, 2012
• Actual Primary Completion Date: Dec 13, 2018
• Actual Study Completion Date: Sep 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Veliparib with Temozolomide Veliparib 40 mg twice daily (BID) Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.	Drug: Veliparib; Other Names: ABT-888 ; Drug: Temozolomide; Other Names: Temodal
Placebo Comparator: Placebo with Carboplatin and Paclitaxel Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Drug: Placebo; Drug: Carboplatin; Drug: Paclitaxel; Other Names: Taxol
Experimental: Veliparib with Carboplatin and Paclitaxel Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Drug: Veliparib; Other Names: ABT-888 ; Drug: Carboplatin; Drug: Paclitaxel; Other Names: Taxol

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) [Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.]

   PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.

Secondary Outcome Measures

1. Overall Survival (OS) [From Cycle 1 Day 1 until participant's death or 3 years post discontinuation (data cutoff date: 04 March 2016); maximum duration of follow up for OS was 72 months.]

   Time to death for a given participant was defined as the number of months from the day the participant is randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurs while the participant was still taking study drug, or after the participant discontinued study drug. If a participant had not died, then the data will be censored at the date when the participant was last known to be alive.

2. Clinical Benefit Rate (CBR) at Week 18 [Week 18]

   CBR: percentage of participants who were progression-free at 18 weeks, defined as complete response (CR), partial response (PR), stable disease (SD) or non-CR/non-disease progression (PD) per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 0 mm. PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters (SOD). PD: >= 20% increase in the SOD of target lesions, taking as reference the smallest SOD recorded since the treatment started (baseline or after) or the appearance of >=1 new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after).

3. Objective Response Rate (ORR) [Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for ORR was 34 months.]

   The objective response rate, defined as percentage of participants with a confirmed CR or PR based on RECIST 1.1 criteria. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 0 mm. PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline SODs.

4. Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score [Baseline, Week 18]

   EORTC QLQ-CIPN20 sensory subscale score was calculated following the standard scoring algorithm, transformed to a 0 (low quality of life) to 100 (best quality of life) scale. A positive change from baseline indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.

• Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.

• Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.

• If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.

• Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.

• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.

• Subject must have adequate bone marrow, renal and hepatic function.

• Subject must not be pregnant or plan to conceive a child.

Exclusion Criteria:

• Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.

• More than 2 prior lines of cytotoxic chemotherapy.

• Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.

• Prior taxane therapy for metastatic breast cancer.

• A history of or evidence of brain metastases or leptomeningeal disease.

• A history of uncontrolled seizure disorder.

• Pre-existing neuropathy from any cause in excess of Grade 1.

• Known history of allergic reaction to cremophor/paclitaxel.

• Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.

• Pregnant or breastfeeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham - Main /ID# 62994	Birmingham	Alabama	United States	35233
2	Banner MD Anderson Cancer Ctr /ID# 118695	Gilbert	Arizona	United States	85234
3	University of Arkansas for Medical Sciences /ID# 60750	Little Rock	Arkansas	United States	72205
4	Moore UC San Diego Cancer Center /ID# 60754	La Jolla	California	United States	92093
5	The Angeles Clinic and Researc /ID# 60743	Los Angeles	California	United States	90025
6	Stanford University School of Med /ID# 65488	Stanford	California	United States	94305-2200
7	Cedars-Sinai Medical Center - West Hollywood /ID# 60760	West Hollywood	California	United States	90048
8	Univ of Colorado Cancer Center /ID# 60751	Aurora	Colorado	United States	80045
9	Lynn Cancer Institute, Boca /ID# 60749	Boca Raton	Florida	United States	33486
10	Holy Cross Hospital /ID# 62995	Fort Lauderdale	Florida	United States	33308
11	Moffitt Cancer Center /ID# 60746	Tampa	Florida	United States	33612-9416
12	Florida Cancer Specialists - East /ID# 60762	West Palm Beach	Florida	United States	33401
13	University of Illinois - Chicago /ID# 106175	Chicago	Illinois	United States	60607
14	Northwestern University Feinberg School of Medicine /ID# 60755	Chicago	Illinois	United States	60611-2927
15	Rush University Medical Center /ID# 65489	Chicago	Illinois	United States	60612
16	Midwestern Regional CTC /ID# 60744	Zion	Illinois	United States	60099
17	Johns Hopkins University /ID# 60759	Baltimore	Maryland	United States	21287
18	Massachusetts General Hospital /ID# 64582	Boston	Massachusetts	United States	02114
19	Dana-Farber Cancer Institute /ID# 93833	Boston	Massachusetts	United States	02215
20	William Beaumont Hospital /ID# 95417	Royal Oak	Michigan	United States	48073-6710
21	Washington University-School of Medicine /ID# 62724	Saint Louis	Missouri	United States	63110
22	Beth Israel Medical Center /ID# 87993	New York	New York	United States	10003
23	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222	New York	New York	United States	10065-6007
24	Duke University Medical Center /ID# 60747	Durham	North Carolina	United States	27710-3000
25	Penn State University and Milton S. Hershey Medical Center /ID# 62723	Hershey	Pennsylvania	United States	17033
26	University of Pennsylvania /ID# 60753	Philadelphia	Pennsylvania	United States	19104-5502
27	University of Pittsburgh MC /ID# 60758	Pittsburgh	Pennsylvania	United States	15260
28	University of Pittsburgh MC /ID# 65486	Pittsburgh	Pennsylvania	United States	15260
29	Medical University of South Carolina /ID# 60752	Charleston	South Carolina	United States	29425
30	The West Clinic /ID# 65487	Memphis	Tennessee	United States	38120
31	The West Clinic /ID# 94599	Memphis	Tennessee	United States	38120
32	The West Clinic /ID# 94600	Memphis	Tennessee	United States	38120
33	UT Southwestern Medical Center /ID# 60745	Dallas	Texas	United States	75390-7208
34	Houston Methodist Hospital - Scurlock Tower /ID# 60742	Houston	Texas	United States	77030
35	Coiba /Id# 65219	Berazategui, Buenos Aires		Argentina	1884
36	ISIS Centro Especializado /ID# 65226	Santa Fe		Argentina	3000
37	The Prince of Wales Hospital /ID# 63271	Randwick	New South Wales	Australia	2031
38	Southern Medical Day Care Ctr /ID# 63274	Wollongong	New South Wales	Australia	2500
39	Mater Misericordiae Limited /ID# 63276	South Brisbane	Queensland	Australia	4101
40	Royal Adelaide Hospital /ID# 63280	Adelaide	South Australia	Australia	5000
41	Royal Hobart Hospital /ID# 63279	Hobart	Tasmania	Australia	7000
42	Peter MacCallum Cancer Ctr /ID# 63272	Melbourne	Victoria	Australia	3000
43	Royal Melbourne Hospital /ID# 63278	Parkville	Victoria	Australia	3050
44	Mount Hospital /ID# 65262	Perth	Western Australia	Australia	6000
45	Cliniques Universitaires Saint Luc /ID# 96135	Woluwe-Saint-Lambert	Bruxelles-Capitale	Belgium	1200
46	Grand Hôpital de Charleroi /ID# 96136	Charleroi	Hainaut	Belgium	6000
47	AZ St-Jan Brugge-Oostende AV /ID# 107315	Brugge	West-Vlaanderen	Belgium	8000
48	UZ Antwerp /ID# 96945	Edegem		Belgium	2650
49	UZ Leuven /ID# 96138	Leuven		Belgium	3000
50	CHU UCL Namur /ID# 110595	Namur		Belgium	5000
51	Hospital Bruno Born / Sociedade Beneficencia e Caridade de Lajeado /ID# 65247	Lajeado	Rio Grande Do Sul	Brazil	95900-000
52	Irmandade da Santa Casa de /ID# 65244	Porto Alegre	Rio Grande Do Sul	Brazil	90020-090
53	Hospital de Clinicas de Porto Alegre /ID# 65242	Porto Alegre	Rio Grande Do Sul	Brazil	90035-903
54	Sunnybrook Health Sciences Ctr /ID# 77373	Toronto	Ontario	Canada	M4N 3M5
55	Jewish General Hospital /ID# 69893	Montreal	Quebec	Canada	H3T 1E2
56	CHUM - Notre-Dame Hospital /ID# 67862	Montréal	Quebec	Canada	H2X 0A9
57	CHUQ-Hospital St. Sacrement /ID# 68902	Quebec City	Quebec	Canada	G1S 4L8
58	Masarykuv onkologicky ustav /ID# 65170	Brno		Czechia	656 53
59	Palacky University /ID# 63923	Olomouc		Czechia	779 00
60	Vseobecna Fakultni Nemocnice /ID# 65172	Prague		Czechia	128 08
61	Vejle Sygehus /ID# 65173	Vejle	Syddanmark	Denmark	7100
62	Rigshospitalet, Finsen Centre /ID# 67822	Copenhagen		Denmark	2100
63	Docrates Cancer Center /ID# 63924	Helsinki		Finland	00180
64	Tampere University Hospital /ID# 102417	Tampere		Finland	33521
65	Hopital Universitaire Purpan /ID# 98815	Toulouse	Haute-Garonne	France	31059
66	Institut Curie /ID# 63926	Paris CEDEX 05	Ile-de-France	France	75248
67	Institut de Cancer de l'Ouest /ID# 63927	St Herblain CEDEX	Loire-Atlantique	France	44805
68	Centre Leon Berard /ID# 106675	Lyon CEDEX 08	Rhone	France	69373
69	Pays-Basque Ctr Oncology/Radio /ID# 65176	Bayonne		France	64100
70	Institut Paoli-Calmettes /ID# 65175	Marseille		France	13273
71	Hopital Rene Huguenin /ID# 65177	Saint-cloud		France	92210
72	Centre Paul Strauss /ID# 100275	Strasbourg		France	67065
73	Bajcsy-Zsilinszky Korhaz /ID# 65179	Budapest		Hungary	1106
74	Debreceni Egyetem Klinikai Kozpont /ID# 65178	Debrecen		Hungary	4032
75	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928	Szolnok		Hungary	5004
76	Rabin Medical Center /ID# 63929	Petakh Tikva	Tel-Aviv	Israel	4941492
77	Soroka University Medical Center /ID# 65180	Be'er Sheva		Israel	84101
78	Assaf Harofeh Medical Center /ID# 65181	Be'er Ya'akov		Israel	70300
79	Rambam Health Care Campus /ID# 63930	Haifa		Israel	3109601
80	Shaare Zedek Medical Center /ID# 116575	Jerusalem		Israel	91031
81	Gastroenterology Institute, Division of Medicine /ID# 63931	Jerusalem		Israel	91120
82	Sheba Medical Center /ID# 63932	Ramat Gan		Israel	5239424
83	Kaplan Medical Center /ID# 63933	Rehovot		Israel	76100
84	Erasmus Medisch Centrum /ID# 96275	Rotterdam		Netherlands	3015 CE
85	Haukeland University Hospital /ID# 67982	Bergen	Hordaland	Norway	5021
86	Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975	Rzeszów	Podkarpackie	Poland	35-021
87	Centrum Onkologii Lukaszczyka /ID# 73393	Bydgoszcz		Poland	85-796
88	Olsztynski Osrodek Onkologi /ID# 71060	Olsztyn		Poland	10-513
89	NZOZ Centrum Medyczne HCP /ID# 68102	Poznan		Poland	61-485
90	Wielkopolskie Centrum Onkologi /ID# 71061	Poznan		Poland	61-866
91	S.C. lanuli Med Consult SRL /ID# 106955	Bucharest		Romania	020962
92	lnstitutul Oncologic Trestiore /ID# 96742	Bucharest		Romania	022328
93	Spitalul Clinic Judetean de Urgenta /ID# 96741	Cluj		Romania	400006
94	Inst Oncology Prof. Chiricuta /ID# 96740	Cluj		Romania	400010
95	Sc Oncolab Srl /Id# 96745	Craiova		Romania	200385
96	Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 65263	Moscow	Moskva	Russian Federation	115478
97	Chelyabinsk Reg Clin Oncology /ID# 63938	Chelyabinsk		Russian Federation	454087
98	State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 102415	Murmansk		Russian Federation	183047
99	City Clinical Hospital 1 /ID# 102416	Novosibirsk		Russian Federation	630075
100	Pyatigorsk Oncology Dispensary /ID# 65264	Pyatigorsk		Russian Federation	357502
101	Birch A Healthcare /ID# 65265	St. Petersburg		Russian Federation	197183
102	N.N. Petrov Research Inst Onc /ID# 65269	St. Petersburg		Russian Federation	197758
103	N.N. Petrov Research Inst Onc /ID# 78973	St. Petersburg		Russian Federation	197758
104	Volgograd Reg Onc Disp #3 /ID# 98035	Volzhsky		Russian Federation	404130
105	Hospital Universitario Vall d'Hebron /ID# 97415	Barcelona		Spain	08035
106	Hospital Santa Creu i Sant Pau /ID# 97418	Barcelona		Spain	08041
107	Hospital General Universitario Gregorio Maranon /ID# 97417	Madrid		Spain	28007
108	Hospital Universitario HM Sanchinarro /ID# 97416	Madrid		Spain	28050
109	Hospital Universitario Virgen de la Victoria /ID# 97976	Malaga		Spain	29010
110	Hospital Clinico Universitario de Valencia /ID# 97975	Valencia		Spain	46010
111	Skanes Universitetssjukhus /ID# 96475	Malmö	Skane Lan	Sweden	214 28
112	Sahlgrenska University Hosp /ID# 97715	Goteborg		Sweden	413 45
113	Karolinska Univ Sjukhuset /ID# 98037	Solna		Sweden	17176
114	Cherkassy Regional Onc Ctr /ID# 97698	Cherkasy		Ukraine	18000
115	Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 63940	Dnipro		Ukraine	49102
116	Communal non-profit enterprise Regional Center of Oncology /ID# 97696	Kharkiv		Ukraine	61070
117	Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 63941	Lviv		Ukraine	79031
118	Odessa National Medical Univ /ID# 65278	Odesa		Ukraine	65026
119	Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 97697	Poltava		Ukraine	36011
120	Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 65280	Sumy		Ukraine	40022

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

• Study Protocol - Jun 7, 2019
• Statistical Analysis Plan - Apr 7, 2019

More Information

Publications

• Han HS, Diéras V, Robson M, Palácová M, Marcom PK, Jager A, Bondarenko I, Citrin D, Campone M, Telli ML, Domchek SM, Friedlander M, Kaufman B, Garber JE, Shparyk Y, Chmielowska E, Jakobsen EH, Kaklamani V, Gradishar W, Ratajczak CK, Nickner C, Qin Q, Qian J, Shepherd SP, Isakoff SJ, Puhalla S. Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study. Ann Oncol. 2018 Jan 1;29(1):154-161. doi: 10.1093/annonc/mdx505.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT01506609
• Other Study ID Numbers: M12-895; 2011-002913-12
• First Posted: Jan 10, 2012
• Last Update Posted: Oct 25, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by AbbVie: PARP; TMZ; Temodal; Carboplatin; veliparib; BRCA2 mutation carrier; Breast cancer; Metastatic breast cancer; temozolomide; BRCA1 mutation carrier; ABT-888; Paclitaxel; Recurrent breast cancer; Temodar; Locally recurrent
• Additional relevant MeSH terms: Breast Neoplasms; Paclitaxel; Carboplatin; Temozolomide; Veliparib

Study Results

Participant Flow

Recruitment Details

Under the original protocol, approximately 4 participants were randomized in a 1:1:1 ratio (Group 1) to 1 of the 3 treatment arms (1 participant in veliparib 40 mg twice daily (BID)+temozolomide (TMZ) arm and a total of 3 participants in either the veliparib 80 mg BID+carboplatin+paclitaxel or the placebo BID+carboplatin+paclitaxel arms) at approximately 3 research sites. Participants randomized under the original protocol were in Group 1, and were not included in the primary efficacy analyses.

Pre-assignment Detail

Following approval of Amendment 1, the veliparib dose in combination with carboplatin and paclitaxel was increased to 120 mg BID. Participants were randomized 1:1:1 ratio (Group 2) to 1 of the 3 treatment arms (veliparib 40 mg BID+TMZ, veliparib 120 mg BID+carboplatin+paclitaxel, placebo BID+carboplatin+paclitaxel) at approximately 120 research sites. Participants randomized following approval of Amendment 1 were in Group 2 and were included in the primary efficacy analyses.

Arm/Group Title	Group 1 Placebo + Carboplatin/Paclitaxel	Group 1 Veliparib + Carboplatin/Paclitaxel	Group 1 Veliparib + TMZ	Group 2 Placebo + Carboplatin/Paclitaxel	Group 2 Veliparib + Carboplatin/Paclitaxel	Group 2 Veliparib + TMZ
Arm/Group Description	Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.	Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
Period Title: Overall Study
STARTED	2	1	1	99	97	94
COMPLETED	0	0	0	0	1	0
NOT COMPLETED	2	1	1	99	96	94

Baseline Characteristics

Arm/Group Title	Group 1 Placebo + Carboplatin/Paclitaxel	Group 1 Veliparib + Carboplatin/Paclitaxel	Group 1 Veliparib + TMZ	Group 2 Placebo + Carboplatin/Paclitaxel	Group 2 Veliparib + Carboplatin/Paclitaxel	Group 2 Veliparib + TMZ	Total
Arm/Group Description	Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.	Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.	Total of all reporting groups
Overall Participants	2	1	1	99	97	94	294
Age, Customized (Count of Participants)
< 45 years	2 100%	1 100%	0 0%	47 47.5%	49 50.5%	41 43.6%	140 47.6%
45 to 64 years	0 0%	0 0%	1 100%	49 49.5%	47 48.5%	46 48.9%	143 48.6%
>= 65 years	0 0%	0 0%	0 0%	3 3%	1 1%	7 7.4%	11 3.7%
Sex: Female, Male (Count of Participants)
Female	2 100%	1 100%	1 100%	97 98%	95 97.9%	92 97.9%	288 98%
Male	0 0%	0 0%	0 0%	2 2%	2 2.1%	2 2.1%	6 2%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	6 6.1%	7 7.2%	5 5.3%	18 6.1%
No Ethnicity	2 100%	1 100%	1 100%	93 93.9%	90 92.8%	89 94.7%	276 93.9%
Race/Ethnicity, Customized (Count of Participants)
White	2 100%	1 100%	1 100%	93 93.9%	92 94.8%	83 88.3%	272 92.5%
Black	0 0%	0 0%	0 0%	4 4%	3 3.1%	10 10.6%	17 5.8%
Asian	0 0%	0 0%	0 0%	0 0%	1 1%	1 1.1%	2 0.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	1 1%	0 0%	1 0.3%
Other, Not Specified	0 0%	0 0%	0 0%	2 2%	0 0%	0 0%	2 0.7%

Outcome Measures

1. Primary Outcome

Title	Progression-Free Survival (PFS)
Description	PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.
Time Frame	Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.

Outcome Measure Data

Analysis Population Description

Group 2: All randomized participants with suspected deleterious or deleterious breast cancer gene (BRCA)1 or BRCA2 mutation determined by sponsor core lab.

Arm/Group Title	Group 2 Placebo + Carboplatin/Paclitaxel	Group 2 Veliparib + Carboplatin/Paclitaxel	Group 2 Veliparib + TMZ
Arm/Group Description	Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
Measure Participants	98	95	91
Median (95% Confidence Interval) [months]	12.3	14.1	7.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 2 Placebo + Carboplatin/Paclitaxel, Group 2 Veliparib + Carboplatin/Paclitaxel
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.227
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.789
	Confidence Interval	(2-Sided) 95%; 0.536 to 1.162
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2 Placebo + Carboplatin/Paclitaxel, Group 2 Veliparib + TMZ
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.858
	Confidence Interval	(2-Sided) 95%; 1.278 to 2.702
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Overall Survival (OS)
Description	Time to death for a given participant was defined as the number of months from the day the participant is randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurs while the participant was still taking study drug, or after the participant discontinued study drug. If a participant had not died, then the data will be censored at the date when the participant was last known to be alive.
Time Frame	From Cycle 1 Day 1 until participant's death or 3 years post discontinuation (data cutoff date: 04 March 2016); maximum duration of follow up for OS was 72 months.

Outcome Measure Data

Analysis Population Description

Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab.

Arm/Group Title	Group 2 Placebo + Carboplatin/Paclitaxel	Group 2 Veliparib + Carboplatin/Paclitaxel	Group 2 Veliparib + TMZ
Arm/Group Description	Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
Measure Participants	98	95	91
Median (95% Confidence Interval) [months]	25.4	28.3	19.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 2 Placebo + Carboplatin/Paclitaxel, Group 2 Veliparib + Carboplatin/Paclitaxel
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.368
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.848
	Confidence Interval	(2-Sided) 95%; 0.590 to 1.218
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2 Placebo + Carboplatin/Paclitaxel, Group 2 Veliparib + TMZ
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.512
	Confidence Interval	(2-Sided) 95%; 1.074 to 2.127
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Clinical Benefit Rate (CBR) at Week 18
Description	CBR: percentage of participants who were progression-free at 18 weeks, defined as complete response (CR), partial response (PR), stable disease (SD) or non-CR/non-disease progression (PD) per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 0 mm. PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters (SOD). PD: >= 20% increase in the SOD of target lesions, taking as reference the smallest SOD recorded since the treatment started (baseline or after) or the appearance of >=1 new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after).
Time Frame	Week 18

Outcome Measure Data

Analysis Population Description

Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab.

Arm/Group Title	Group 2 Placebo + Carboplatin/Paclitaxel	Group 2 Veliparib + Carboplatin/Paclitaxel	Group 2 Veliparib + TMZ
Arm/Group Description	Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
Measure Participants	98	95	91
Number (95% Confidence Interval) [percentage of participants]	87.0 4350%	90.7 9070%	73.0 7300%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 2 Placebo + Carboplatin/Paclitaxel, Group 2 Veliparib + Carboplatin/Paclitaxel
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.434
	Comments	P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2 Placebo + Carboplatin/Paclitaxel, Group 2 Veliparib + TMZ
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments	P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.
	Method	Cochran-Mantel-Haenszel
	Comments

4. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	The objective response rate, defined as percentage of participants with a confirmed CR or PR based on RECIST 1.1 criteria. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 0 mm. PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline SODs.
Time Frame	Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for ORR was 34 months.

Outcome Measure Data

Analysis Population Description

Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab. Participants with at least 1 measurable lesion at baseline.

Arm/Group Title	Group 2 Placebo + Carboplatin/Paclitaxel	Group 2 Veliparib + Carboplatin/Paclitaxel	Group 2 Veliparib + TMZ
Arm/Group Description	Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
Measure Participants	80	72	70
Number (95% Confidence Interval) [percentage of participants]	61.3 3065%	77.8 7780%	28.6 2860%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 2 Placebo + Carboplatin/Paclitaxel, Group 2 Veliparib + Carboplatin/Paclitaxel
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments	P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2 Placebo + Carboplatin/Paclitaxel, Group 2 Veliparib + TMZ
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.
	Method	Cochran-Mantel-Haenszel
	Comments

5. Secondary Outcome

Title	Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score
Description	EORTC QLQ-CIPN20 sensory subscale score was calculated following the standard scoring algorithm, transformed to a 0 (low quality of life) to 100 (best quality of life) scale. A positive change from baseline indicates improvement.
Time Frame	Baseline, Week 18

Outcome Measure Data

Analysis Population Description

Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab. Participants with a baseline and post baseline value. Per protocol, this outcome measure was not planned for the Veliparib + TMZ arm.

Arm/Group Title	Group 2 Placebo + Carboplatin/Paclitaxel	Group 2 Veliparib + Carboplatin/Paclitaxel
Arm/Group Description	Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.
Measure Participants	62	69
Mean (Standard Deviation) [score on a scale]	13.94 (14.123)	11.24 (13.954)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 2 Placebo + Carboplatin/Paclitaxel, Group 2 Veliparib + Carboplatin/Paclitaxel
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.354
	Comments	ANCOVA with treatment arm and baseline value as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares (LS) Mean of Difference
	Estimated Value	-2.302
	Confidence Interval	(2-Sided) 95%; -7.20 to 2.60
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.476
	Estimation Comments

Adverse Events

Time Frame	All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively.
Adverse Event Reporting Description	All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Arm/Group Title	Group 1 Placebo + Carboplatin/Paclitaxel		Group 1 Veliparib + Carboplatin/Paclitaxel		Group 1 Veliparib + TMZ		Group 2 Placebo + Carboplatin/Paclitaxel		Group 2 Veliparib + Carboplatin/Paclitaxel		Group 2 Veliparib + TMZ
Arm/Group Description	Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.		Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.		Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.		Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.		Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.		Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.
All Cause Mortality
	Group 1 Placebo + Carboplatin/Paclitaxel		Group 1 Veliparib + Carboplatin/Paclitaxel		Group 1 Veliparib + TMZ		Group 2 Placebo + Carboplatin/Paclitaxel		Group 2 Veliparib + Carboplatin/Paclitaxel		Group 2 Veliparib + TMZ
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		1/1 (100%)		1/1 (100%)		65/96 (67.7%)		59/93 (63.4%)		76/93 (81.7%)
Serious Adverse Events
	Group 1 Placebo + Carboplatin/Paclitaxel		Group 1 Veliparib + Carboplatin/Paclitaxel		Group 1 Veliparib + TMZ		Group 2 Placebo + Carboplatin/Paclitaxel		Group 2 Veliparib + Carboplatin/Paclitaxel		Group 2 Veliparib + TMZ
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)		0/1 (0%)		26/96 (27.1%)		32/93 (34.4%)		16/93 (17.2%)
Blood and lymphatic system disorders
ANAEMIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	2/93 (2.2%)	2	0/93 (0%)	0
FEBRILE NEUTROPENIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	7/93 (7.5%)	7	1/93 (1.1%)	1
LYMPHADENOPATHY	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
NEUTROPENIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
PANCYTOPENIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
THROMBOCYTOPENIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	2/93 (2.2%)	2	1/93 (1.1%)	1
Cardiac disorders
ATRIAL FIBRILLATION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
CARDIAC TAMPONADE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
PERICARDIAL EFFUSION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	2	0/93 (0%)	0	0/93 (0%)	0
TACHYCARDIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
Gastrointestinal disorders
ABDOMINAL PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	3/93 (3.2%)	3	1/93 (1.1%)	1
ABDOMINAL PAIN UPPER	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
DIARRHOEA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	1/93 (1.1%)	1	0/93 (0%)	0
NAUSEA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	2	1/93 (1.1%)	1
VOMITING	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	1/93 (1.1%)	3	1/93 (1.1%)	1
General disorders
ASTHENIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
DISEASE PROGRESSION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
FATIGUE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
PYREXIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	4/93 (4.3%)	4	0/93 (0%)	0
SUDDEN DEATH	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
Hepatobiliary disorders
BILE DUCT OBSTRUCTION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
HEPATOTOXICITY	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
Immune system disorders
DRUG HYPERSENSITIVITY	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	1/93 (1.1%)	1	0/93 (0%)	0
Infections and infestations
BACTERAEMIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
BREAST CELLULITIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	2/93 (2.2%)	2	0/93 (0%)	0
DEVICE RELATED INFECTION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	0/93 (0%)	0	0/93 (0%)	0
DIVERTICULITIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
EMPYEMA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
GASTROENTERITIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
HERPES ZOSTER	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
MASTITIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	2	0/93 (0%)	0
OTITIS MEDIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
PNEUMONIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	1/93 (1.1%)	1	0/93 (0%)	0
PYELONEPHRITIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
SEPSIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
URINARY TRACT INFECTION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
VIRAL UPPER RESPIRATORY TRACT INFECTION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
FEMUR FRACTURE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
PROCEDURAL HYPOTENSION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
RECALL PHENOMENON	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
THORACIC VERTEBRAL FRACTURE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
Investigations
BLOOD CREATININE INCREASED	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
EJECTION FRACTION DECREASED	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
OXYGEN SATURATION DECREASED	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
Metabolism and nutrition disorders
DEHYDRATION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
HYPOCALCAEMIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
Musculoskeletal and connective tissue disorders
BONE PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
NECK PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
PATHOLOGICAL FRACTURE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	0/93 (0%)	0	0/93 (0%)	0
CANCER PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
MALIGNANT NEOPLASM PROGRESSION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	5/93 (5.4%)	5	4/93 (4.3%)	4
Nervous system disorders
CENTRAL NERVOUS SYSTEM LESION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
HAEMORRHAGE INTRACRANIAL	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
HEADACHE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
SEIZURE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
SYNCOPE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	1/93 (1.1%)	1	0/93 (0%)	0
VOCAL CORD PARALYSIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
Psychiatric disorders
ANXIETY	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
MENTAL STATUS CHANGES	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
Renal and urinary disorders
URINARY RETENTION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
Respiratory, thoracic and mediastinal disorders
DYSPNOEA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
EPISTAXIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
PLEURAL EFFUSION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	1/93 (1.1%)	1
PNEUMOTHORAX	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	1/93 (1.1%)	1
PULMONARY EMBOLISM	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
Vascular disorders
THROMBOPHLEBITIS SUPERFICIAL	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1 Placebo + Carboplatin/Paclitaxel		Group 1 Veliparib + Carboplatin/Paclitaxel		Group 1 Veliparib + TMZ		Group 2 Placebo + Carboplatin/Paclitaxel		Group 2 Veliparib + Carboplatin/Paclitaxel		Group 2 Veliparib + TMZ
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		1/1 (100%)		1/1 (100%)		93/96 (96.9%)		93/93 (100%)		91/93 (97.8%)
Blood and lymphatic system disorders
ANAEMIA	2/2 (100%)	3	1/1 (100%)	5	0/1 (0%)	0	49/96 (51%)	113	53/93 (57%)	139	26/93 (28%)	52
LEUKOPENIA	1/2 (50%)	2	1/1 (100%)	3	0/1 (0%)	0	27/96 (28.1%)	88	28/93 (30.1%)	112	16/93 (17.2%)	55
LYMPHOPENIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/96 (4.2%)	4	8/93 (8.6%)	30	7/93 (7.5%)	8
NEUTROPENIA	2/2 (100%)	13	1/1 (100%)	3	0/1 (0%)	0	70/96 (72.9%)	373	68/93 (73.1%)	402	46/93 (49.5%)	211
THROMBOCYTOPENIA	1/2 (50%)	1	1/1 (100%)	5	1/1 (100%)	2	65/96 (67.7%)	239	66/93 (71%)	312	72/93 (77.4%)	187
Cardiac disorders
TACHYCARDIA	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	5/96 (5.2%)	6	2/93 (2.2%)	2	0/93 (0%)	0
Ear and labyrinth disorders
EAR PAIN	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	3/96 (3.1%)	8	4/93 (4.3%)	4	3/93 (3.2%)	3
VERTIGO	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	5/96 (5.2%)	6	2/93 (2.2%)	3	2/93 (2.2%)	2
Eye disorders
DRY EYE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	5/96 (5.2%)	6	4/93 (4.3%)	4	4/93 (4.3%)	6
LACRIMATION INCREASED	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	5/96 (5.2%)	7	4/93 (4.3%)	6	2/93 (2.2%)	2
VISION BLURRED	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	7/96 (7.3%)	7	12/93 (12.9%)	15	1/93 (1.1%)	1
Gastrointestinal disorders
ABDOMINAL PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	16/96 (16.7%)	19	20/93 (21.5%)	23	15/93 (16.1%)	24
ABDOMINAL PAIN UPPER	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	7/96 (7.3%)	14	11/93 (11.8%)	15	7/93 (7.5%)	14
CONSTIPATION	0/2 (0%)	0	1/1 (100%)	2	0/1 (0%)	0	28/96 (29.2%)	49	38/93 (40.9%)	57	38/93 (40.9%)	57
DIARRHOEA	0/2 (0%)	0	1/1 (100%)	1	1/1 (100%)	2	25/96 (26%)	44	37/93 (39.8%)	63	19/93 (20.4%)	27
DRY MOUTH	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/96 (4.2%)	4	6/93 (6.5%)	6	8/93 (8.6%)	8
DYSPEPSIA	1/2 (50%)	1	1/1 (100%)	2	0/1 (0%)	0	15/96 (15.6%)	23	9/93 (9.7%)	17	5/93 (5.4%)	5
DYSPHAGIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	2/93 (2.2%)	2	6/93 (6.5%)	7
GASTRITIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	5/93 (5.4%)	5	0/93 (0%)	0
GASTROOESOPHAGEAL REFLUX DISEASE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/96 (4.2%)	4	9/93 (9.7%)	14	4/93 (4.3%)	4
MELAENA	0/2 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/96 (0%)	0	1/93 (1.1%)	1	1/93 (1.1%)	1
NAUSEA	1/2 (50%)	1	1/1 (100%)	2	1/1 (100%)	3	56/96 (58.3%)	133	66/93 (71%)	152	69/93 (74.2%)	166
STOMATITIS	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	11/96 (11.5%)	20	11/93 (11.8%)	15	5/93 (5.4%)	6
TOOTHACHE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	5	5/93 (5.4%)	5	3/93 (3.2%)	3
VOMITING	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	22/96 (22.9%)	36	26/93 (28%)	41	40/93 (43%)	81
General disorders
ASTHENIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	15/96 (15.6%)	29	23/93 (24.7%)	61	17/93 (18.3%)	59
CHILLS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/96 (3.1%)	3	7/93 (7.5%)	8	2/93 (2.2%)	3
FATIGUE	1/2 (50%)	1	1/1 (100%)	1	0/1 (0%)	0	57/96 (59.4%)	141	47/93 (50.5%)	93	44/93 (47.3%)	76
INFLUENZA LIKE ILLNESS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/96 (4.2%)	5	5/93 (5.4%)	8	3/93 (3.2%)	4
MALAISE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	3/93 (3.2%)	4	5/93 (5.4%)	5
MUCOSAL INFLAMMATION	0/2 (0%)	0	1/1 (100%)	2	0/1 (0%)	0	7/96 (7.3%)	10	9/93 (9.7%)	10	3/93 (3.2%)	3
NON-CARDIAC CHEST PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	6/96 (6.3%)	6	6/93 (6.5%)	6	1/93 (1.1%)	1
OEDEMA PERIPHERAL	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	14/96 (14.6%)	18	13/93 (14%)	18	3/93 (3.2%)	5
PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/96 (4.2%)	7	14/93 (15.1%)	20	5/93 (5.4%)	5
PYREXIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	18/96 (18.8%)	23	15/93 (16.1%)	16	9/93 (9.7%)	12
Immune system disorders
DRUG HYPERSENSITIVITY	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	16/96 (16.7%)	26	18/93 (19.4%)	24	0/93 (0%)	0
Infections and infestations
EAR INFECTION	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	0/93 (0%)	0	0/93 (0%)	0
GASTROENTERITIS	0/2 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	1/96 (1%)	1	4/93 (4.3%)	4	2/93 (2.2%)	2
INFLUENZA	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	3/96 (3.1%)	5	3/93 (3.2%)	4	4/93 (4.3%)	4
NASOPHARYNGITIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	12/96 (12.5%)	13	12/93 (12.9%)	18	5/93 (5.4%)	5
SINUSITIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	7/96 (7.3%)	7	5/93 (5.4%)	6	1/93 (1.1%)	1
UPPER RESPIRATORY TRACT INFECTION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	10/96 (10.4%)	11	20/93 (21.5%)	28	14/93 (15.1%)	17
URINARY TRACT INFECTION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	9/96 (9.4%)	14	12/93 (12.9%)	13	13/93 (14%)	13
Injury, poisoning and procedural complications
CONTUSION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/96 (4.2%)	4	2/93 (2.2%)	2	5/93 (5.4%)	5
INFUSION RELATED REACTION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	5/96 (5.2%)	10	5/93 (5.4%)	10	0/93 (0%)	0
Investigations
ALANINE AMINOTRANSFERASE INCREASED	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	10/96 (10.4%)	17	13/93 (14%)	20	6/93 (6.5%)	6
ASPARTATE AMINOTRANSFERASE INCREASED	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	10/96 (10.4%)	12	10/93 (10.8%)	16	10/93 (10.8%)	12
BLOOD ALKALINE PHOSPHATASE INCREASED	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	5/93 (5.4%)	11	5/93 (5.4%)	5
BLOOD BILIRUBIN INCREASED	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
PLATELET COUNT DECREASED	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/96 (1%)	1	5/93 (5.4%)	12	1/93 (1.1%)	2
WEIGHT DECREASED	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	6/96 (6.3%)	8	4/93 (4.3%)	5	3/93 (3.2%)	3
WEIGHT INCREASED	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	4/96 (4.2%)	5	2/93 (2.2%)	5	1/93 (1.1%)	1
Metabolism and nutrition disorders
DECREASED APPETITE	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	20/96 (20.8%)	27	22/93 (23.7%)	30	21/93 (22.6%)	29
DEHYDRATION	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	0/96 (0%)	0	3/93 (3.2%)	3	0/93 (0%)	0
HYPERGLYCAEMIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	5/96 (5.2%)	7	3/93 (3.2%)	4	1/93 (1.1%)	1
HYPOKALAEMIA	0/2 (0%)	0	1/1 (100%)	3	0/1 (0%)	0	6/96 (6.3%)	7	9/93 (9.7%)	12	1/93 (1.1%)	1
HYPOMAGNESAEMIA	0/2 (0%)	0	1/1 (100%)	2	0/1 (0%)	0	11/96 (11.5%)	18	17/93 (18.3%)	21	2/93 (2.2%)	2
Musculoskeletal and connective tissue disorders
ARTHRALGIA	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	31/96 (32.3%)	45	34/93 (36.6%)	62	14/93 (15.1%)	18
BACK PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	23/96 (24%)	40	28/93 (30.1%)	43	24/93 (25.8%)	32
BONE PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	12/96 (12.5%)	16	21/93 (22.6%)	37	6/93 (6.5%)	6
MUSCLE SPASMS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	9/96 (9.4%)	9	10/93 (10.8%)	14	6/93 (6.5%)	6
MUSCULAR WEAKNESS	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	2/96 (2.1%)	3	3/93 (3.2%)	3	1/93 (1.1%)	1
MUSCULOSKELETAL CHEST PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	7/96 (7.3%)	7	4/93 (4.3%)	5	7/93 (7.5%)	8
MUSCULOSKELETAL PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	7/96 (7.3%)	8	14/93 (15.1%)	16	8/93 (8.6%)	8
MYALGIA	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	20/96 (20.8%)	38	32/93 (34.4%)	56	8/93 (8.6%)	9
NECK PAIN	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	3/96 (3.1%)	4	4/93 (4.3%)	4	2/93 (2.2%)	3
PAIN IN EXTREMITY	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	23/96 (24%)	39	17/93 (18.3%)	55	13/93 (14%)	15
Nervous system disorders
DISTURBANCE IN ATTENTION	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	0/96 (0%)	0	0/93 (0%)	0	0/93 (0%)	0
DIZZINESS	0/2 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	18/96 (18.8%)	28	23/93 (24.7%)	31	7/93 (7.5%)	8
DYSGEUSIA	2/2 (100%)	2	0/1 (0%)	0	0/1 (0%)	0	12/96 (12.5%)	34	18/93 (19.4%)	19	12/93 (12.9%)	12
HEADACHE	1/2 (50%)	1	0/1 (0%)	0	1/1 (100%)	1	31/96 (32.3%)	41	34/93 (36.6%)	61	27/93 (29%)	50
HYPOAESTHESIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	6/96 (6.3%)	7	4/93 (4.3%)	4	2/93 (2.2%)	2
LETHARGY	0/2 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/96 (0%)	0	1/93 (1.1%)	1	0/93 (0%)	0
NEUROPATHY PERIPHERAL	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	34/96 (35.4%)	64	42/93 (45.2%)	60	7/93 (7.5%)	7
PARAESTHESIA	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	17/96 (17.7%)	32	17/93 (18.3%)	24	4/93 (4.3%)	4
PERIPHERAL SENSORY NEUROPATHY	1/2 (50%)	1	1/1 (100%)	1	0/1 (0%)	0	22/96 (22.9%)	47	31/93 (33.3%)	64	4/93 (4.3%)	5
Psychiatric disorders
ANXIETY	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	7/96 (7.3%)	7	10/93 (10.8%)	13	5/93 (5.4%)	9
DEPRESSION	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	6/96 (6.3%)	7	7/93 (7.5%)	8	4/93 (4.3%)	4
INSOMNIA	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	23/96 (24%)	26	14/93 (15.1%)	16	20/93 (21.5%)	21
Renal and urinary disorders
DYSURIA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/96 (4.2%)	4	5/93 (5.4%)	5	1/93 (1.1%)	2
Reproductive system and breast disorders
BREAST PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	6/96 (6.3%)	6	1/93 (1.1%)	1	1/93 (1.1%)	1
Respiratory, thoracic and mediastinal disorders
COUGH	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	15/96 (15.6%)	23	21/93 (22.6%)	27	13/93 (14%)	23
DYSPNOEA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	22/96 (22.9%)	28	14/93 (15.1%)	16	8/93 (8.6%)	11
EPISTAXIS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	6/96 (6.3%)	7	7/93 (7.5%)	8	3/93 (3.2%)	8
OROPHARYNGEAL PAIN	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	7/93 (7.5%)	8	2/93 (2.2%)	2
RHINORRHOEA	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	3/96 (3.1%)	4	8/93 (8.6%)	10	3/93 (3.2%)	3
Skin and subcutaneous tissue disorders
ALOPECIA	1/2 (50%)	1	1/1 (100%)	1	0/1 (0%)	0	55/96 (57.3%)	69	61/93 (65.6%)	79	10/93 (10.8%)	13
DERMATITIS ACNEIFORM	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	3/93 (3.2%)	3	0/93 (0%)	0
ERYTHEMA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	6/96 (6.3%)	7	6/93 (6.5%)	7	1/93 (1.1%)	1
PRURITUS	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	6/96 (6.3%)	7	12/93 (12.9%)	16	9/93 (9.7%)	9
RASH	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	17/96 (17.7%)	23	7/93 (7.5%)	10	5/93 (5.4%)	7
URTICARIA	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	2/96 (2.1%)	2	0/93 (0%)	0	1/93 (1.1%)	1
Vascular disorders
HAEMATOMA	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	5/96 (5.2%)	5	3/93 (3.2%)	4	6/93 (6.5%)	10
HOT FLUSH	1/2 (50%)	1	0/1 (0%)	0	1/1 (100%)	1	8/96 (8.3%)	12	14/93 (15.1%)	22	11/93 (11.8%)	13
HYPERTENSION	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	4/96 (4.2%)	6	2/93 (2.2%)	2	5/93 (5.4%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.