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Bridalveil: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Sponsor
Gilead Sciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT01732926
Collaborator
(none)
475
Enrollment
144
Locations
2
Arms
40.4
Actual Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
475 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Actual Study Start Date :
Jan 2, 2013
Actual Primary Completion Date :
May 17, 2016
Actual Study Completion Date :
May 17, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rituximab + Bendamustine + Idelalisib

Participants will receive rituximab + bendamustine + idelalisib.

Drug: Idelalisib
150 mg tablet administered orally twice daily
Other Names:
  • Zydelig®
  • CAL-101
  • GS-1101

    • Drug: Rituximab
    375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
    Other Names:
  • Rituxan®
  • MabThera®

    • Drug: Bendamustine
    90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
    Other Names:
  • Treanda®

    		•
    Experimental: Rituximab + Bendamustine + Placebo

    Participants will receive rituximab + bendamustine + placebo.

    Drug: Rituximab
    375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
    Other Names:
  • Rituxan®
  • MabThera®

    • Drug: Bendamustine
    90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
    Other Names:
  • Treanda®

    • Drug: Placebo
    Tablet administered orally twice daily

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival (PFS) []

      PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).

    Secondary Outcome Measures

    1. Complete Response Rate (CR) []

      Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.

    2. Overall Response Rate (ORR) []

      Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.

    3. Lymph Node Response Rate []

      Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.

    4. Overall Survival (OS) []

      Overall survival is defined as the interval from randomization to death from any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following

    1. Follicular lymphoma (FL) Grade 1, 2, or 3a

    2. Small lymphocytic lymphoma (SLL)

    3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)

    4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

    Key Exclusion Criteria:

    • History of lymphoid malignancy other than those allowed per inclusion criteria.

    • Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.

    • Prior treatment with bendamustine that was not effective.

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clearview Cancer Institute Huntsville Alabama United States 35805
    2 Ironwood Cancer and Research Center Chandler Arizona United States 85224
    3 Comprehensive Blood and Cancer Center (Bakersfield) Bakersfield California United States 93309
    4 Saint Jude Heritage Healthcare (TORI) Fullerton California United States 92835
    5 Pacific Shores Medical Group Long Beach California United States 90813
    6 Cancer Care Associates Redondo Beach California United States 90277
    7 San Luis Obispo Oncology and Hematology San Luis Obispo California United States 93401
    8 Cancer Center of Santa Barbara Santa Barbara California United States 93105
    9 Central Coast Medical Oncology Group Santa Maria California United States 93454
    10 St Joseph Heritage Healthcare System Santa Rosa California United States 95403
    11 Kaiser Permanente Vallejo Medical Center Vallejo California United States 94589
    12 Sylvester Comprehensive Cancer Center/UMHC Deerfield Beach Florida United States 33442
    13 Cancer Specialists of North Florida Jacksonville Florida United States 32256
    14 Northwest Georgia Oncology Centers, PC Marietta Georgia United States 30060
    15 Rush University Medical Center Chicago Illinois United States 60612
    16 Joliet Oncology Hematology Associates Ltd. Joliet Illinois United States 60435
    17 Cancer Center of Kansas Wichita Kansas United States 67214
    18 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    19 North Shore Hematology/Oncology Associates East Setauket New York United States 11733
    20 Weill Cornell Medical College New York New York United States 10065
    21 Signal Point Clinical Research Center, LLC Middletown Ohio United States 45042
    22 Hollings Cancer Center Charleston South Carolina United States 29425
    23 Bon Secours Saint Francis Hospital Greenville South Carolina United States 29607
    24 Texas Oncology, P.A. Bedford Texas United States 76022
    25 Charles A. Sammons Cancer Center Dallas Texas United States 75246
    26 Texas Oncology, P.A. Denton Texas United States 76210
    27 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    28 Texas Oncology, P.A. Harlingen Texas United States 78550-8321
    29 Texas Oncology, P.A. Weslaco Texas United States 78596-6608
    30 Swedish Medical Center Seattle Washington United States 98104
    31 Northwest Medical Specialists Tacoma Washington United States 98405
    32 Aurora BayCare Medical Center Green Bay Wisconsin United States 54308
    33 Froedtert Hospital and Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    34 Prince of Wales Hospital Randwick New South Wales Australia 2031
    35 Haematology and Oncology Clinics of Australia Gold Coast South Brisbane Queensland Australia 4101
    36 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    37 Adelaide Cancer Centre Kurralta Park South Australia Australia 5037
    38 Box Hill Hospital Box Hill Victoria Australia 3128
    39 Monash Medical Centre Clayton Victoria Australia 3168
    40 Saint Vincent's Hospital Fitzroy Victoria Australia 3065
    41 Western Hospital Footscray Victoria Australia 3011
    42 Royal Perth Hospital Perth Western Australia Australia 6000
    43 Tom Baker Cancer Center Calgary Alberta Canada T2N 2T9
    44 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    45 Fraser Clinical Trials, Inc. New Westminster British Columbia Canada V3L 3W4
    46 BC Cancer Agency - Vancouver Centre Vancouver British Columbia Canada V5Z 4E6
    47 Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research Halifax Nova Scotia Canada B3H 1V7
    48 Royal Victoria Regional Health Centre Barrie Ontario Canada L4M 6M2
    49 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    50 Hôpital Charles Lemoyne Greenfield Park Quebec Canada J4V 2H1
    51 McGill University Health Centre Montréal Quebec Canada H4A 3JI
    52 Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec Canada J1H 5N4
    53 Centre Hospitalier Affilie Universitaire de Quebec Quebec Canada G1J 1Z4
    54 CancerCare Manitoba Winnipeg Canada R3E 0V9
    55 Fakultní Nemocnice Ostrava Ostrava - Poruba Severomoravsky KRAJ Czechia 708 52
    56 Fakultní nemocnice Brno Brno Czechia 625 00
    57 Fakultní nemocnice Hradec Králové Hradec Králové Czechia 500 05
    58 CHR Metz Metz Cedex 03 Alsace France 57085
    59 Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre Strasbourg Cedex Alsace France 67098
    60 Institut Bergonié Bordeaux Cedex Aquitaine France 33076
    61 Centre Henri-Becquerel Rouen Cedex 1 Haute-normandie France 76038
    62 Hôpital Necker-Enfants Malades Paris Ile-de-france France 75015
    63 Centre Jean Bernard Le Mans PAYS DE LA Loire France 72000
    64 Centre Hospitalier Lyon Sud Pierre Bénite Cedex Rhone-alpes France 69495
    65 Centre Hospitalier Universitaire Brest Brest Cedex France 29609
    66 Centre Hospitalier de Dunkerque Dunkerque France 59385
    67 Centre Hospitalier Départmental La Roche sur Yon La Roche sur Yon France 85925
    68 Centre Léon Bérard Lyon Cedex 08 France 69373
    69 Institut Paoli Calmettes Marseille France 13273
    70 Hôpital Hôtel-Dieu Nantes cedex 1 France 44093
    71 Centre Hospitalier Universitaire de Poitiers Poitiers Cedex France 86021
    72 Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau Tours France 37044
    73 Institut Gustave Roussy Villejuif France 94805
    74 Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen Baden-wuerttemberg Germany 78054
    75 Gemeinschaftspraxis Dres. Söling Und Siehl Kassel Hessen Germany 34117
    76 Vivantes Klinikum am Urban Berlin Germany 10967
    77 Charite - Campus Virchow Berlin Germany 13353
    78 Klinikum der Ludwig-Maximilians-Universität München München Germany 81377
    79 Barzilai Medical Center Ashkelon Israel 78278
    80 Soroka University Medical Center Beer Sheva Israel 84101
    81 Rambam Health Corp. Haifa Israel 31096
    82 Hadassah Medical Organization, Ein Kerem Jerusalem Israel 91120
    83 Centro di Riferimento Oncologico di Aviano Aviano Italy 33081
    84 Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi Bologna Italy 40138
    85 Spedali Civili Di Brescia Azienda Ospedaliera Brescia Italy 25123
    86 IRCCS Azienda Ospedaliera Universitaria San Martino Genova Italy 16132
    87 Ospedale San Raffaele-IRCCS Milano Italy 20132
    88 Azienda Ospedaliera Ospedale Niguarda Ca' Granda Milano Italy 20162
    89 Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara Novara Italy 28100
    90 Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro Italy 61122
    91 Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto Piacenza Italy 29100
    92 Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte Siena Italy 53100
    93 Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino Italy 10126
    94 Dong-A University Medical Center Busan Korea, Republic of 602-715
    95 Seoul National University Hospital Seoul Korea, Republic of 110-744
    96 Samsung Medical Center Seoul Korea, Republic of 135-710
    97 Asan Medical Center Seoul Korea, Republic of 138-736
    98 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-952
    99 Malopolskie Centrum Medyczne S.C. Kraków Poland 30-510
    100 Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku Lublin Poland 20-081
    101 Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi Lódz Poland 93-510
    102 Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim Olsztyn Poland 10-228
    103 Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Slupsk Poland 76-200
    104 Centralny Szpital Kliniczny MSW w Warszawie Warszawa Poland 02-507
    105 Instytut Hematologii i Transfuzjologii Warszawa Poland 02-776
    106 Centrum Onkologii i Hipertermii Warszawa Poland 02-781
    107 Sverdlovsk Regional Clinical Hospital #1 Ekaterinburg Russian Federation 620102
    108 Central City Hospital # 7 Ekaterinburg Russian Federation 620137
    109 N. N. Blokhin Russian Cancer Research Center Moscow Russian Federation 115478
    110 Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko Nizhniy Novgorod Russian Federation 603126
    111 Ryazan Regional Clinical Hospital Ryazan Russian Federation 390039
    112 FGU Russian Scientific Research Institute of Hematology and Transfusiology Saint Petersburg Russian Federation 191024
    113 FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies" Saint Petersburg Russian Federation 197341
    114 Saint Petersburg I.P. Pavlov State Medical University Saint-Petersburg Russian Federation 197022
    115 Saratov State Medical University Saratov Russian Federation 140012
    116 State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1" Volgograd Russian Federation 400138
    117 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222
    118 Hospital Universitari Germans Trias i Pujol Badalona Spain 08916
    119 Hospital Universitario La Princesa Madrid Spain 28006
    120 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    121 Hospital Clínico Universitario de Salamanca Salamanca Spain 37007
    122 Hospital Universitario de Canarias San Cristobal de La Laguna Spain 38320
    123 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    124 Hospital Universitari i Politecnic La Fé de Valencia Valencia Spain 46026
    125 Karolinska Universitetssjukhuset Huddinge Stockholm Sweden 141 86
    126 Länssjukhuset Ryhov Jönköping Sweden 551 85
    127 Changhua Christian Hospital Changhua city Taiwan 500
    128 China Medical University Hospital Taichung Taiwan 404
    129 National Cheng-Kung University Hospital Tainan Taiwan 70403
    130 National Taiwan University Hospital Taipei Taiwan 10002
    131 Kent and Canterbury Hospital Canterbury England United Kingdom CT1 3NG
    132 University Hospital Coventry Coventry England United Kingdom CV2 2DX
    133 Royal Bournemouth General Hospital Dorset England United Kingdom BH7 7DW
    134 Leeds Teaching Hospitals NHS Trust Leeds England United Kingdom LS9 7TF
    135 Barts and The London NHS Trust London England United Kingdom EC1M 6BQ
    136 University College London Hospitals National Health Society Foundation Trust London England United Kingdom NW1 2PG
    137 Guys and Saint Thomas NHS Foundation Trust London England United Kingdom SE1 9RT
    138 Imperial College Healthcare NHS Trust London England United Kingdom W12 0NN
    139 Maidstone Hospital Maidstone England United Kingdom ME16 9QQ
    140 Christie Hospital NHS Foundation Trust Manchester England United Kingdom M20 4BX
    141 Oxford University Hospitals NHS Trust Oxford England United Kingdom OX3 7LE
    142 Southampton General Hospital Southampton England United Kingdom SO16 6YD
    143 Mount Vernon Hospital Middlesex United Kingdom HA6 2RN
    144 New Cross Hospital Wolverhampton United Kingdom WV10 0QP

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01732926
    Other Study ID Numbers:
    • GS-US-313-0125
    • 2012-004034-42
    First Posted:
    Nov 26, 2012
    Last Update Posted:
    Nov 16, 2018
    Last Verified:
    Mar 1, 2017
    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
    Keywords provided by Gilead Sciences
    iNHL
    indolent NHL
    follicular lymphoma
    CAL-101
    rituximab
    bendamustine
    small lymphocytic lymphoma
    lymphoplasmacytoid lymphoma
    Waldenstrom macroglobulinemia
    LPL
    WM
    Marginal zone lymphoma
    MZL
    SLL
    FL
    GS-1101
    PI3K inhibitor
    idelalisib
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Rituximab
    Bendamustine Hydrochloride
    Idelalisib

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 02 January 2013. The last study visit occurred on 17 May 2016.
    Pre-assignment Detail 581 participants were screened.
    Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Arm/Group Description Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
    Period Title: Overall Study
    STARTED 320 155
    COMPLETED 53 45
    NOT COMPLETED 267 110

    Baseline Characteristics

    Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab Total
    Arm/Group Description Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Total of all reporting groups
    Overall Participants 320 155 475
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    62
    (10.5)
    62
    (11.1)
    62
    (10.9)
    Sex: Female, Male (Count of Participants)
    Female
    132
    41.3%
    58
    37.4%
    190
    40%
    Male
    188
    58.8%
    97
    62.6%
    285
    60%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    26
    8.1%
    8
    5.2%
    34
    7.2%
    Black or African American
    2
    0.6%
    2
    1.3%
    4
    0.8%
    White
    247
    77.2%
    122
    78.7%
    369
    77.7%
    Other
    4
    1.3%
    2
    1.3%
    6
    1.3%
    Not Permitted
    41
    12.8%
    21
    13.5%
    62
    13.1%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    16
    5%
    8
    5.2%
    24
    5.1%
    Not Hispanic or Latino
    262
    81.9%
    129
    83.2%
    391
    82.3%
    Not Permitted
    42
    13.1%
    18
    11.6%
    60
    12.6%
    Region of Enrollment (Count of Participants)
    Russian Federation
    16
    5%
    11
    7.1%
    27
    5.7%
    United States
    37
    11.6%
    12
    7.7%
    49
    10.3%
    United Kingdom
    33
    10.3%
    20
    12.9%
    53
    11.2%
    Spain
    21
    6.6%
    11
    7.1%
    32
    6.7%
    Canada
    47
    14.7%
    19
    12.3%
    66
    13.9%
    Czech Republic
    12
    3.8%
    7
    4.5%
    19
    4%
    Sweden
    3
    0.9%
    2
    1.3%
    5
    1.1%
    Taiwan
    7
    2.2%
    2
    1.3%
    9
    1.9%
    Poland
    25
    7.8%
    11
    7.1%
    36
    7.6%
    Korea, Republic of
    10
    3.1%
    2
    1.3%
    12
    2.5%
    Italy
    21
    6.6%
    14
    9%
    35
    7.4%
    Israel
    6
    1.9%
    2
    1.3%
    8
    1.7%
    France
    36
    11.3%
    18
    11.6%
    54
    11.4%
    Australia
    44
    13.8%
    23
    14.8%
    67
    14.1%
    Germany
    2
    0.6%
    1
    0.6%
    3
    0.6%

    Outcome Measures

    1. Primary Outcome
    Title Progression-free Survival (PFS)
    Description PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).
    Time Frame

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Arm/Group Description Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
    Measure Participants 0 0
    2. Secondary Outcome
    Title Complete Response Rate (CR)
    Description Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.
    Time Frame

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Arm/Group Description Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
    Measure Participants 0 0
    3. Secondary Outcome
    Title Overall Response Rate (ORR)
    Description Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.
    Time Frame

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Arm/Group Description Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
    Measure Participants 0 0
    4. Secondary Outcome
    Title Lymph Node Response Rate
    Description Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
    Time Frame

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Arm/Group Description Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
    Measure Participants 0 0
    5. Secondary Outcome
    Title Overall Survival (OS)
    Description Overall survival is defined as the interval from randomization to death from any cause.
    Time Frame

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.
    Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Arm/Group Description Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
    Measure Participants 0 0

    Adverse Events

    Time Frame Up to 34 months plus 30 days
    Adverse Event Reporting Description Safety Analysis Set: all participants who took at least 1 dose of study drug
    Arm/Group Title Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Arm/Group Description Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions) Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
    All Cause Mortality
    Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 229/317 (72.2%) 58/155 (37.4%)
    Blood and lymphatic system disorders
    Anaemia 8/317 (2.5%) 4/155 (2.6%)
    Aplasia pure red cell 1/317 (0.3%) 0/155 (0%)
    Autoimmune haemolytic anaemia 1/317 (0.3%) 0/155 (0%)
    Febrile bone marrow aplasia 1/317 (0.3%) 0/155 (0%)
    Febrile neutropenia 45/317 (14.2%) 7/155 (4.5%)
    Haemolytic anaemia 0/317 (0%) 1/155 (0.6%)
    Leukocytosis 1/317 (0.3%) 0/155 (0%)
    Leukopenia 1/317 (0.3%) 0/155 (0%)
    Neutropenia 8/317 (2.5%) 3/155 (1.9%)
    Pancytopenia 1/317 (0.3%) 0/155 (0%)
    Thrombocytopenia 4/317 (1.3%) 2/155 (1.3%)
    Cardiac disorders
    Acute myocardial infarction 1/317 (0.3%) 0/155 (0%)
    Angina unstable 1/317 (0.3%) 1/155 (0.6%)
    Arrhythmia supraventricular 1/317 (0.3%) 0/155 (0%)
    Atrial fibrillation 1/317 (0.3%) 1/155 (0.6%)
    Atrioventricular block complete 0/317 (0%) 1/155 (0.6%)
    Cardiac arrest 1/317 (0.3%) 0/155 (0%)
    Cardiac failure 1/317 (0.3%) 0/155 (0%)
    Cardiac failure acute 2/317 (0.6%) 0/155 (0%)
    Cardiac failure congestive 1/317 (0.3%) 0/155 (0%)
    Cardio-respiratory arrest 0/317 (0%) 1/155 (0.6%)
    Coronary artery stenosis 1/317 (0.3%) 0/155 (0%)
    Dilatation ventricular 1/317 (0.3%) 0/155 (0%)
    Myocardial infarction 1/317 (0.3%) 0/155 (0%)
    Right ventricular failure 1/317 (0.3%) 0/155 (0%)
    Tachyarrhythmia 1/317 (0.3%) 0/155 (0%)
    Ventricular arrhythmia 1/317 (0.3%) 0/155 (0%)
    Ear and labyrinth disorders
    Ear pain 1/317 (0.3%) 0/155 (0%)
    Vertigo 1/317 (0.3%) 0/155 (0%)
    Eye disorders
    Ophthalmoplegia 1/317 (0.3%) 0/155 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 1/317 (0.3%) 0/155 (0%)
    Abdominal pain 3/317 (0.9%) 0/155 (0%)
    Colitis 9/317 (2.8%) 0/155 (0%)
    Colitis ischaemic 1/317 (0.3%) 0/155 (0%)
    Diarrhoea 14/317 (4.4%) 2/155 (1.3%)
    Dyspepsia 1/317 (0.3%) 1/155 (0.6%)
    Dysphagia 1/317 (0.3%) 0/155 (0%)
    Faecaloma 0/317 (0%) 1/155 (0.6%)
    Gastric haemorrhage 1/317 (0.3%) 0/155 (0%)
    Gastrointestinal pain 1/317 (0.3%) 0/155 (0%)
    Gingival pain 1/317 (0.3%) 0/155 (0%)
    Haematochezia 1/317 (0.3%) 0/155 (0%)
    Incarcerated umbilical hernia 0/317 (0%) 1/155 (0.6%)
    Nausea 6/317 (1.9%) 1/155 (0.6%)
    Oesophageal ulcer haemorrhage 1/317 (0.3%) 0/155 (0%)
    Oesophagitis 2/317 (0.6%) 0/155 (0%)
    Pancreatitis 1/317 (0.3%) 0/155 (0%)
    Small intestinal obstruction 1/317 (0.3%) 0/155 (0%)
    Vomiting 8/317 (2.5%) 1/155 (0.6%)
    General disorders
    Asthenia 1/317 (0.3%) 0/155 (0%)
    Chest pain 2/317 (0.6%) 0/155 (0%)
    Chills 2/317 (0.6%) 0/155 (0%)
    Death 1/317 (0.3%) 0/155 (0%)
    Device related thrombosis 1/317 (0.3%) 0/155 (0%)
    Fatigue 1/317 (0.3%) 0/155 (0%)
    Hypothermia 0/317 (0%) 1/155 (0.6%)
    Mucosal inflammation 1/317 (0.3%) 2/155 (1.3%)
    Oedema 1/317 (0.3%) 0/155 (0%)
    Oedema peripheral 1/317 (0.3%) 0/155 (0%)
    Pain 1/317 (0.3%) 0/155 (0%)
    Pyrexia 67/317 (21.1%) 2/155 (1.3%)
    Hepatobiliary disorders
    Cholecystitis acute 1/317 (0.3%) 0/155 (0%)
    Cholelithiasis 2/317 (0.6%) 0/155 (0%)
    Cholestasis 1/317 (0.3%) 0/155 (0%)
    Hepatitis toxic 2/317 (0.6%) 0/155 (0%)
    Hepatocellular injury 2/317 (0.6%) 0/155 (0%)
    Hepatotoxicity 1/317 (0.3%) 0/155 (0%)
    Immune system disorders
    Anaphylactic reaction 0/317 (0%) 1/155 (0.6%)
    Drug hypersensitivity 3/317 (0.9%) 1/155 (0.6%)
    Hypersensitivity 4/317 (1.3%) 0/155 (0%)
    Infections and infestations
    Acute sinusitis 1/317 (0.3%) 0/155 (0%)
    Anal abscess 0/317 (0%) 1/155 (0.6%)
    Arthritis infective 1/317 (0.3%) 0/155 (0%)
    Aspergillus infection 1/317 (0.3%) 0/155 (0%)
    Atypical pneumonia 1/317 (0.3%) 1/155 (0.6%)
    Bacteraemia 1/317 (0.3%) 0/155 (0%)
    Bronchiolitis 0/317 (0%) 1/155 (0.6%)
    Bronchitis 2/317 (0.6%) 0/155 (0%)
    Campylobacter infection 1/317 (0.3%) 0/155 (0%)
    Candida infection 1/317 (0.3%) 0/155 (0%)
    Cellulitis 5/317 (1.6%) 1/155 (0.6%)
    Clostridium difficile colitis 3/317 (0.9%) 0/155 (0%)
    Clostridium difficile infection 1/317 (0.3%) 1/155 (0.6%)
    Conjunctivitis 2/317 (0.6%) 0/155 (0%)
    Cytomegalovirus colitis 1/317 (0.3%) 0/155 (0%)
    Cytomegalovirus hepatitis 1/317 (0.3%) 0/155 (0%)
    Cytomegalovirus infection 6/317 (1.9%) 0/155 (0%)
    Cytomegalovirus viraemia 1/317 (0.3%) 0/155 (0%)
    Dengue fever 0/317 (0%) 1/155 (0.6%)
    Device related infection 1/317 (0.3%) 0/155 (0%)
    Empyema 0/317 (0%) 1/155 (0.6%)
    Encephalitis 0/317 (0%) 1/155 (0.6%)
    Enteritis infectious 1/317 (0.3%) 0/155 (0%)
    Erysipelas 0/317 (0%) 1/155 (0.6%)
    Gastroenteritis 0/317 (0%) 1/155 (0.6%)
    Gastroenteritis norovirus 1/317 (0.3%) 0/155 (0%)
    Gastroenteritis viral 0/317 (0%) 2/155 (1.3%)
    Gingivitis 0/317 (0%) 1/155 (0.6%)
    Groin abscess 2/317 (0.6%) 0/155 (0%)
    Haematoma infection 1/317 (0.3%) 0/155 (0%)
    Herpes simplex 1/317 (0.3%) 0/155 (0%)
    Herpes zoster 2/317 (0.6%) 1/155 (0.6%)
    Infected skin ulcer 0/317 (0%) 1/155 (0.6%)
    Infection 1/317 (0.3%) 1/155 (0.6%)
    Infectious colitis 1/317 (0.3%) 0/155 (0%)
    Influenza 4/317 (1.3%) 1/155 (0.6%)
    Listeria sepsis 1/317 (0.3%) 0/155 (0%)
    Lower respiratory tract infection 5/317 (1.6%) 3/155 (1.9%)
    Lower respiratory tract infection fungal 1/317 (0.3%) 0/155 (0%)
    Lung infection 3/317 (0.9%) 0/155 (0%)
    Neutropenic sepsis 4/317 (1.3%) 2/155 (1.3%)
    Oesophageal candidiasis 1/317 (0.3%) 0/155 (0%)
    Oral candidiasis 1/317 (0.3%) 0/155 (0%)
    Otitis media chronic 1/317 (0.3%) 1/155 (0.6%)
    Pneumocystis jirovecii infection 1/317 (0.3%) 0/155 (0%)
    Pneumocystis jirovecii pneumonia 9/317 (2.8%) 0/155 (0%)
    Pneumonia 24/317 (7.6%) 4/155 (2.6%)
    Pneumonia bacterial 2/317 (0.6%) 0/155 (0%)
    Pneumonia chlamydial 1/317 (0.3%) 0/155 (0%)
    Pneumonia cytomegaloviral 1/317 (0.3%) 0/155 (0%)
    Pneumonia fungal 1/317 (0.3%) 0/155 (0%)
    Pseudomonal bacteraemia 1/317 (0.3%) 0/155 (0%)
    Pseudomonal sepsis 1/317 (0.3%) 0/155 (0%)
    Respiratory syncytial virus infection 1/317 (0.3%) 0/155 (0%)
    Respiratory tract infection 0/317 (0%) 2/155 (1.3%)
    Salmonellosis 1/317 (0.3%) 0/155 (0%)
    Sepsis 9/317 (2.8%) 1/155 (0.6%)
    Septic shock 2/317 (0.6%) 2/155 (1.3%)
    Sinusitis 3/317 (0.9%) 0/155 (0%)
    Staphylococcal sepsis 1/317 (0.3%) 0/155 (0%)
    Systemic mycosis 1/317 (0.3%) 0/155 (0%)
    Upper respiratory tract infection 4/317 (1.3%) 0/155 (0%)
    Urinary tract infection 6/317 (1.9%) 1/155 (0.6%)
    Urosepsis 2/317 (0.6%) 0/155 (0%)
    Varicella 3/317 (0.9%) 0/155 (0%)
    Varicella zoster virus infection 0/317 (0%) 1/155 (0.6%)
    Viral upper respiratory tract infection 1/317 (0.3%) 0/155 (0%)
    Injury, poisoning and procedural complications
    Craniocerebral injury 0/317 (0%) 1/155 (0.6%)
    Fall 1/317 (0.3%) 0/155 (0%)
    Femoral neck fracture 1/317 (0.3%) 0/155 (0%)
    Hip fracture 2/317 (0.6%) 0/155 (0%)
    Infusion related reaction 5/317 (1.6%) 3/155 (1.9%)
    Lower limb fracture 1/317 (0.3%) 0/155 (0%)
    Procedural pain 1/317 (0.3%) 0/155 (0%)
    Road traffic accident 0/317 (0%) 1/155 (0.6%)
    Sacroiliac fracture 1/317 (0.3%) 0/155 (0%)
    Splenic rupture 1/317 (0.3%) 0/155 (0%)
    Stoma site haemorrhage 1/317 (0.3%) 0/155 (0%)
    Wrist fracture 1/317 (0.3%) 0/155 (0%)
    Investigations
    Alanine aminotransferase increased 14/317 (4.4%) 0/155 (0%)
    Aspartate aminotransferase increased 12/317 (3.8%) 0/155 (0%)
    Blood bilirubin increased 1/317 (0.3%) 0/155 (0%)
    Blood creatinine increased 1/317 (0.3%) 0/155 (0%)
    Blood lactate dehydrogenase increased 2/317 (0.6%) 0/155 (0%)
    Electrocardiogram QT prolonged 1/317 (0.3%) 0/155 (0%)
    Neutrophil count decreased 0/317 (0%) 3/155 (1.9%)
    Transaminases increased 2/317 (0.6%) 0/155 (0%)
    Weight decreased 1/317 (0.3%) 0/155 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 1/317 (0.3%) 0/155 (0%)
    Dehydration 6/317 (1.9%) 1/155 (0.6%)
    Hyperkalaemia 1/317 (0.3%) 0/155 (0%)
    Hyperuricaemia 1/317 (0.3%) 0/155 (0%)
    Hypokalaemia 1/317 (0.3%) 0/155 (0%)
    Hyponatraemia 1/317 (0.3%) 1/155 (0.6%)
    Tumour lysis syndrome 4/317 (1.3%) 0/155 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/317 (0.6%) 0/155 (0%)
    Back pain 1/317 (0.3%) 0/155 (0%)
    Intervertebral disc protrusion 1/317 (0.3%) 0/155 (0%)
    Joint swelling 1/317 (0.3%) 0/155 (0%)
    Muscular weakness 1/317 (0.3%) 0/155 (0%)
    Polyarthritis 1/317 (0.3%) 0/155 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anal cancer 0/317 (0%) 1/155 (0.6%)
    B-cell lymphoma 0/317 (0%) 1/155 (0.6%)
    Breast cancer 0/317 (0%) 1/155 (0.6%)
    Clear cell renal cell carcinoma 1/317 (0.3%) 0/155 (0%)
    Endometrial adenocarcinoma 1/317 (0.3%) 0/155 (0%)
    Lung adenocarcinoma 2/317 (0.6%) 0/155 (0%)
    Malignant melanoma 1/317 (0.3%) 0/155 (0%)
    Myelodysplastic syndrome 2/317 (0.6%) 1/155 (0.6%)
    Oesophageal carcinoma 0/317 (0%) 1/155 (0.6%)
    Plasma cell myeloma 1/317 (0.3%) 0/155 (0%)
    Richter's syndrome 1/317 (0.3%) 0/155 (0%)
    Squamous cell carcinoma 1/317 (0.3%) 0/155 (0%)
    Nervous system disorders
    Balance disorder 1/317 (0.3%) 0/155 (0%)
    Central nervous system lesion 1/317 (0.3%) 0/155 (0%)
    Cerebrovascular accident 2/317 (0.6%) 0/155 (0%)
    Complex regional pain syndrome 1/317 (0.3%) 0/155 (0%)
    Embolic stroke 1/317 (0.3%) 0/155 (0%)
    Facial paralysis 1/317 (0.3%) 0/155 (0%)
    Lethargy 1/317 (0.3%) 0/155 (0%)
    Mixed dementia 1/317 (0.3%) 0/155 (0%)
    Presyncope 0/317 (0%) 1/155 (0.6%)
    Spinal cord compression 1/317 (0.3%) 0/155 (0%)
    Syncope 1/317 (0.3%) 0/155 (0%)
    Transient ischaemic attack 1/317 (0.3%) 0/155 (0%)
    VIth nerve paralysis 1/317 (0.3%) 0/155 (0%)
    Product Issues
    Device dislocation 1/317 (0.3%) 0/155 (0%)
    Psychiatric disorders
    Confusional state 1/317 (0.3%) 1/155 (0.6%)
    Renal and urinary disorders
    Acute kidney injury 6/317 (1.9%) 2/155 (1.3%)
    Nephrotic syndrome 1/317 (0.3%) 0/155 (0%)
    Renal failure 3/317 (0.9%) 0/155 (0%)
    Renal impairment 1/317 (0.3%) 0/155 (0%)
    Urinary retention 1/317 (0.3%) 0/155 (0%)
    Reproductive system and breast disorders
    Prostatitis 0/317 (0%) 1/155 (0.6%)
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 1/317 (0.3%) 0/155 (0%)
    Acute respiratory failure 2/317 (0.6%) 0/155 (0%)
    Aspiration 1/317 (0.3%) 0/155 (0%)
    Asthma 1/317 (0.3%) 0/155 (0%)
    Atelectasis 1/317 (0.3%) 0/155 (0%)
    Bronchitis chronic 1/317 (0.3%) 0/155 (0%)
    Chronic obstructive pulmonary disease 1/317 (0.3%) 0/155 (0%)
    Dyspnoea 3/317 (0.9%) 0/155 (0%)
    Hydrothorax 1/317 (0.3%) 0/155 (0%)
    Hypoxia 2/317 (0.6%) 0/155 (0%)
    Lung disorder 2/317 (0.6%) 1/155 (0.6%)
    Lung infiltration 1/317 (0.3%) 0/155 (0%)
    Organising pneumonia 1/317 (0.3%) 0/155 (0%)
    Pleural effusion 5/317 (1.6%) 0/155 (0%)
    Pleurisy 0/317 (0%) 1/155 (0.6%)
    Pneumonia aspiration 1/317 (0.3%) 0/155 (0%)
    Pneumonitis 16/317 (5%) 0/155 (0%)
    Pulmonary embolism 3/317 (0.9%) 0/155 (0%)
    Pulmonary fibrosis 1/317 (0.3%) 0/155 (0%)
    Pulmonary hypertension 1/317 (0.3%) 0/155 (0%)
    Pulmonary mass 1/317 (0.3%) 0/155 (0%)
    Respiratory failure 6/317 (1.9%) 0/155 (0%)
    Skin and subcutaneous tissue disorders
    Angioedema 0/317 (0%) 1/155 (0.6%)
    Blister 1/317 (0.3%) 0/155 (0%)
    Dermatitis allergic 1/317 (0.3%) 0/155 (0%)
    Dermatitis exfoliative 2/317 (0.6%) 0/155 (0%)
    Ecchymosis 1/317 (0.3%) 0/155 (0%)
    Generalised erythema 1/317 (0.3%) 0/155 (0%)
    Pustular psoriasis 1/317 (0.3%) 0/155 (0%)
    Rash 18/317 (5.7%) 0/155 (0%)
    Rash generalised 3/317 (0.9%) 0/155 (0%)
    Rash maculo-papular 5/317 (1.6%) 0/155 (0%)
    Stevens-Johnson syndrome 1/317 (0.3%) 0/155 (0%)
    Toxic epidermal necrolysis 1/317 (0.3%) 0/155 (0%)
    Toxic skin eruption 1/317 (0.3%) 0/155 (0%)
    Urticaria 4/317 (1.3%) 0/155 (0%)
    Vascular disorders
    Aortic stenosis 1/317 (0.3%) 0/155 (0%)
    Deep vein thrombosis 2/317 (0.6%) 1/155 (0.6%)
    Embolism 1/317 (0.3%) 0/155 (0%)
    Hypotension 3/317 (0.9%) 1/155 (0.6%)
    Hypovolaemic shock 1/317 (0.3%) 0/155 (0%)
    Internal haemorrhage 0/317 (0%) 1/155 (0.6%)
    Other (Not Including Serious) Adverse Events
    Idelalisib + Bendamustine + Rituximab Placebo + Bendamustine + Rituximab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 315/317 (99.4%) 147/155 (94.8%)
    Blood and lymphatic system disorders
    Anaemia 51/317 (16.1%) 18/155 (11.6%)
    Leukopenia 18/317 (5.7%) 7/155 (4.5%)
    Neutropenia 122/317 (38.5%) 54/155 (34.8%)
    Thrombocytopenia 37/317 (11.7%) 18/155 (11.6%)
    Gastrointestinal disorders
    Abdominal pain 39/317 (12.3%) 11/155 (7.1%)
    Abdominal pain upper 21/317 (6.6%) 10/155 (6.5%)
    Constipation 74/317 (23.3%) 31/155 (20%)
    Diarrhoea 158/317 (49.8%) 33/155 (21.3%)
    Dry mouth 20/317 (6.3%) 3/155 (1.9%)
    Dyspepsia 28/317 (8.8%) 9/155 (5.8%)
    Gastrooesophageal reflux disease 17/317 (5.4%) 6/155 (3.9%)
    Mouth ulceration 20/317 (6.3%) 4/155 (2.6%)
    Nausea 159/317 (50.2%) 65/155 (41.9%)
    Stomatitis 26/317 (8.2%) 5/155 (3.2%)
    Vomiting 100/317 (31.5%) 25/155 (16.1%)
    General disorders
    Asthenia 43/317 (13.6%) 24/155 (15.5%)
    Chills 39/317 (12.3%) 10/155 (6.5%)
    Fatigue 103/317 (32.5%) 51/155 (32.9%)
    Mucosal inflammation 29/317 (9.1%) 2/155 (1.3%)
    Oedema peripheral 38/317 (12%) 7/155 (4.5%)
    Pyrexia 135/317 (42.6%) 22/155 (14.2%)
    Infections and infestations
    Bronchitis 22/317 (6.9%) 13/155 (8.4%)
    Herpes zoster 19/317 (6%) 7/155 (4.5%)
    Lower respiratory tract infection 14/317 (4.4%) 9/155 (5.8%)
    Nasopharyngitis 17/317 (5.4%) 14/155 (9%)
    Oral candidiasis 17/317 (5.4%) 2/155 (1.3%)
    Pneumonia 16/317 (5%) 2/155 (1.3%)
    Sinusitis 18/317 (5.7%) 11/155 (7.1%)
    Upper respiratory tract infection 58/317 (18.3%) 25/155 (16.1%)
    Urinary tract infection 26/317 (8.2%) 8/155 (5.2%)
    Injury, poisoning and procedural complications
    Infusion related reaction 38/317 (12%) 16/155 (10.3%)
    Investigations
    Alanine aminotransferase increased 65/317 (20.5%) 3/155 (1.9%)
    Aspartate aminotransferase increased 51/317 (16.1%) 4/155 (2.6%)
    Neutrophil count decreased 12/317 (3.8%) 9/155 (5.8%)
    Weight decreased 41/317 (12.9%) 6/155 (3.9%)
    Metabolism and nutrition disorders
    Decreased appetite 65/317 (20.5%) 25/155 (16.1%)
    Hypokalaemia 52/317 (16.4%) 11/155 (7.1%)
    Hypomagnesaemia 19/317 (6%) 2/155 (1.3%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 22/317 (6.9%) 12/155 (7.7%)
    Back pain 23/317 (7.3%) 12/155 (7.7%)
    Musculoskeletal pain 8/317 (2.5%) 8/155 (5.2%)
    Myalgia 21/317 (6.6%) 6/155 (3.9%)
    Pain in extremity 11/317 (3.5%) 8/155 (5.2%)
    Nervous system disorders
    Dizziness 23/317 (7.3%) 10/155 (6.5%)
    Dysgeusia 16/317 (5%) 10/155 (6.5%)
    Headache 45/317 (14.2%) 18/155 (11.6%)
    Neuropathy peripheral 8/317 (2.5%) 9/155 (5.8%)
    Paraesthesia 9/317 (2.8%) 9/155 (5.8%)
    Psychiatric disorders
    Insomnia 40/317 (12.6%) 16/155 (10.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 71/317 (22.4%) 37/155 (23.9%)
    Dyspnoea 40/317 (12.6%) 11/155 (7.1%)
    Oropharyngeal pain 25/317 (7.9%) 10/155 (6.5%)
    Skin and subcutaneous tissue disorders
    Dry skin 20/317 (6.3%) 5/155 (3.2%)
    Erythema 20/317 (6.3%) 4/155 (2.6%)
    Night sweats 16/317 (5%) 6/155 (3.9%)
    Pruritus 54/317 (17%) 22/155 (14.2%)
    Rash 105/317 (33.1%) 16/155 (10.3%)
    Rash maculo-papular 29/317 (9.1%) 5/155 (3.2%)
    Urticaria 16/317 (5%) 4/155 (2.6%)
    Vascular disorders
    Hypotension 16/317 (5%) 5/155 (3.2%)

    Limitations/Caveats

    Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

    More Information

    Certain Agreements

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

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Clinical Trial Disclosures
    Organization Gilead Sciences
    Phone
    Email ClinicalTrialDisclosures@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01732926
    Other Study ID Numbers:
    • GS-US-313-0125
    • 2012-004034-42
    First Posted:
    Nov 26, 2012
    Last Update Posted:
    Nov 16, 2018
    Last Verified:
    Mar 1, 2017