Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04813263
Collaborator
(none)
400
175
45.1
2.3
0.1

Study Details

Study Description

Brief Summary

Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice.

Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan.

Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets.

There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Post-marketing Observational Study for Venetoclax in Patients Diagnosed With Acute Myeloid Leukemia in Japan
    Actual Study Start Date :
    May 28, 2021
    Anticipated Primary Completion Date :
    Apr 30, 2024
    Anticipated Study Completion Date :
    Feb 28, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Participants Treated With Venetoclax

    Participants who are administrated venetoclax for treatment of AML under routine clinical practice.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With ≥ Grade 3 Neutropenia of Venetoclax Regimens With Unfit Acute Myeloid Leukemia (AML) [Up to 52 weeks.]

      Percentage of participants with a high grade (≥ Grade 3) protocol specified neutropenia during and after treatment with venetoclax.

    Secondary Outcome Measures

    1. Percentage of Participants With Febrile Neutropenia and Thrombocytopenia [Up to 52 weeks]

      Percentage of participants with protocol specified febrile neutropenia and thrombocytopenia during and after treatment with venetoclax.

    2. Percentage of Participants With Tumor Lysis Syndrome (TLS) [Up to 52 weeks]

      Percentage of participants with protocol specified TLS during and after treatment with venetoclax.

    3. Percentage of Participants Reported >= Grade 3 Adverse Events (AE)/Adverse Drug Reactions (ADR) [Up to 52 weeks]

      Grade 3 and above AE/ADR are serious adverse event (SAE) that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.

    4. Percentage of Participants Reported Adverse Events (AE)/Adverse Drug Reaction (ADR) [Up to 52 weeks]

      An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.

    5. Percentage of Participants With AE/ADR When Used Concomitantly With CYP3A Inhibitors or Growth Colony Stimulating Factor (G-CSF) [Up to 52 weeks]

      An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.

    6. Percentage of Participants With Composite Complete Remission Rate (CR + CRi) [Up to 52 weeks]

      Composite Complete remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol criteria.

    7. Median Time to Best Response [Up to 52 weeks.]

      Time to Best Response is measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.

    8. Median Treatment Duration [Up to 52 weeks]

      Median time for duration of oral venetoclax treatment in participants with Acute Myeloid Leukemia.

    9. Median Overall Survival [Up to 52 weeks]

      Time from the date of first oral Venetoclax intake to the date of death from any cause.

    10. Median Duration of Composite Complete Remission [Up to 52 weeks]

      Time from the date of first oral Venetoclax intake and the date of the assessment having documented Complete Remission with incomplete Hematologic recovery (CRi).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All participants who are administered venetoclax for treatment of AML.
    Exclusion Criteria:

    None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anjou Kousei Hospital /ID# 244213 Anjo-shi Aichi Japan 446-8602
    2 Aichi Cancer Center Hospital /ID# 243785 Nagoya-shi Aichi Japan 464-8681
    3 Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 242173 Nagoya-shi Aichi Japan 466-8650
    4 Nagoya University Hospital /ID# 246009 Nagoya-shi Aichi Japan 4668560
    5 Toyohashi Municipal Hospital /ID# 243784 Toyohashi-shi Aichi Japan 441-8570
    6 Toyokawa City Hospital /ID# 242707 Toyokawa-shi Aichi Japan 442-8561
    7 Toyota Memorial Hospital /ID# 242175 Toyota-shi Aichi Japan 471-8513
    8 Akita City Hospital /ID# 240008 Akita-shi Akita Japan 010-0933
    9 Aomori Prefectural Central Hospital /ID# 249442 Aomori-shi Aomori Japan 030-8553
    10 National Hospital Organization Hirosaki General Medical Center /ID# 246008 Hirosaki-shi Aomori Japan 036-8545
    11 Asahi General Hospital /ID# 233889 Asahi-shi Chiba Japan 289-2511
    12 Chiba Aoba Municipal Hospital /ID# 240565 Chiba-shi Chiba Japan 260-0852
    13 Chiba University Hospital /ID# 246011 Chiba-shi Chiba Japan 260-8677
    14 Chiba Cancer Center /ID# 248122 Chiba-shi Chiba Japan 260-8717
    15 Chiba Rosai Hospital /ID# 238767 Ichihara-shi Chiba Japan 290-0003
    16 Kameda General Hospital /ID# 241877 Kamogawa-shi Chiba Japan 296-8602
    17 National Cancer Center Hospital East /ID# 241917 Kashiwa-shi Chiba Japan 277-8577
    18 Kimitsu Chuo Hospital /ID# 248776 Kisarazu-shi Chiba Japan 292-8535
    19 Tsudanuma Central General Hospital /ID# 245890 Narashino-shi Chiba Japan 275-0026
    20 Japanese Red Cross Narita Hospital /ID# 243775 Narita-shi Chiba Japan 286-8523
    21 IUHW Narita Hospital /ID# 240574 Narita-shi Chiba Japan 2868520
    22 Matsuyama Shimin Hospital /ID# 243050 Matsuyama-shi Ehime Japan 790-0067
    23 Ehime University Hospital /ID# 244207 Toon-shi Ehime Japan 791-0295
    24 Fukuiken Saiseikai Hospital /ID# 245062 Fukui-shi Fukui Japan 918-8235
    25 Fukuiken Saiseikai Hospital /ID# 246005 Fukui-shi Fukui Japan 918-8235
    26 National Hospital Organization Kyushu Medical Center /ID# 242026 Fukuoka shi Fukuoka Japan 810-8563
    27 Fukuoka Wajiro Hospital /ID# 238755 Fukuoka-shi Fukuoka Japan 811-0213
    28 National Hospital Organization Kyushu Cancer Center /ID# 244217 Fukuoka-shi Fukuoka Japan 811-1395
    29 Kyushu University Hospital /ID# 248781 Fukuoka-shi Fukuoka Japan 812-8582
    30 Fukuoka University Hospital /ID# 244214 Fukuoka-shi Fukuoka Japan 814-0180
    31 Japanese Red Cross Fukuoka Hospital /ID# 241181 Fukuoka-shi Fukuoka Japan 815-8555
    32 Kurume University Hospital /ID# 240885 Kurume-shi Fukuoka Japan 830-0011
    33 St. Mary's Hospital /ID# 242332 Kurume-shi Fukuoka Japan 830-8543
    34 Omuta City Hospital /ID# 246823 Omuta-shi Fukuoka Japan 836-0861
    35 Ohta Nishinouchi Hospital /ID# 243052 Koriyama-shi Fukushima Japan 963-8558
    36 Shirakawa Kosei General Hosp. /ID# 245815 Shirakawa-shi Fukushima Japan 961-0005
    37 Gifu Municipal Hospital /ID# 241156 Gifu-shi Gifu Japan 500-8513
    38 Gifu University Hospital /ID# 241183 Gifu-shi Gifu Japan 501-1194
    39 Gifu Red Cross Hospital /ID# 240562 Gifu-shi Gifu Japan 502-8511
    40 Ogaki Municipal Hospital /ID# 239353 Ogaki-shi Gifu Japan 503-8502
    41 Japanese Red Cross Takayama Hospital /ID# 240568 高山市 Gifu Japan 506-0025
    42 Gunmaken Saiseikai Maebashi Hospital /ID# 239383 Maebashi-shi Gunma Japan 371-0821
    43 Gunma Prefectural Cancer Center /ID# 242177 Ota-shi Gunma Japan 373-8550
    44 National Hospital Organization Shibukawa Medical Center /ID# 245026 Shibukawa-shi Gunma Japan 377-0280
    45 Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 240880 Hiroshima-shi Hiroshima Japan 730-8619
    46 Mihara Shiromachi Hospital /ID# 246754 Mihara Hiroshima Japan 723-0014
    47 Steel Memorial Muroran Hospita /ID# 231383 Muroran-shi Hokkaido Japan 050-0076
    48 Sapporo Hokushin Hospital /ID# 241878 Sapporo-shi Hokkaido Japan 004-0052
    49 Hokkaido University Hospital /ID# 244223 Sapporo-shi Hokkaido Japan 060-8648
    50 Aiiku Hospital /ID# 239047 Sapporo-shi Hokkaido Japan 064-0804
    51 Homecareclinicn-Consept /Id# 239377 Sapporo Hokkaido Japan 003-0803
    52 Tenshi Hospital /ID# 243051 Sapporo Hokkaido Japan 065-0012
    53 Sunagawa City Medical Center /ID# 239382 Sunagawa Hokkaido Japan 073-0164
    54 Wakkanai City Hospital /ID# 243782 Wakkanai City Hokkaido Japan 097-0022
    55 Sapporo Kiyota Hospital /ID# 231385 札幌市 Hokkaido Japan 004-0831
    56 Ako Central Hospital /ID# 239721 Ako-shi Hyogo Japan 678-0241
    57 Hyogo Prefectural Amagasaki General Medical Center /ID# 239355 Amagasaki-shi Hyogo Japan 660-8550
    58 Itami City Hospital /ID# 233888 Itami-shi Hyogo Japan 6640006
    59 Hyogo Prefectural Kobe Children's Hospital /ID# 245817 Kobe-shi Hyogo Japan 650-0047
    60 Kobe City Medical Center General Hospital /ID# 246010 Kobe-shi Hyogo Japan 650-0047
    61 Shinko Hospital /ID# 233782 Kobe-shi Hyogo Japan 651-0072
    62 Konan Medical Center /ID# 246079 Kobe-shi Hyogo Japan 658-0064
    63 Hyogo Prefectural Nishinomiya Hospital /ID# 239354 Nishinomiya-shi Hyogo Japan 662-0918
    64 Hyogo College of Medicine College Hospital /Id# 240569 Nishinomiya-shi Hyogo Japan 663-8501
    65 Hyogo Prefectural Tamba Medical Center /ID# 240884 Tamba-shi Hyogo Japan 669-3464
    66 Hyogo College of Medicine Sasayama Medical Center /ID# 240888 Tanbasasayama-shi Hyogo Japan 669-2321
    67 Hyogo Prefectural Awaji Medical Center /ID# 240823 洲本市 Hyogo Japan 656-0021
    68 National Hospital Organization Mito Medical Center /ID# 239719 Higashi Ibaraki-gun Ibaraki Japan 311-3193
    69 Hitachi General Hospital /ID# 239376 Hitachi-shi Ibaraki Japan 317-0077
    70 JA Toride Medical Center /ID# 240573 Toride-shi Ibaraki Japan 302-0022
    71 University of Tsukuba Hospital /ID# 242023 Tsukuba-shi Ibaraki Japan 305-8576
    72 JCHO Kanazawa Hospital /ID# 239379 Kanazawa-Shi Ishikawa Japan 920-0013
    73 Iwate Prefectural Isawa Hospital /ID# 246819 Oshu-shi Iwate Japan 0230864
    74 Sakaide City Hospital /ID# 240563 Sakaide City Kagawa Japan 7620043
    75 Imamura General Hospital /ID# 234006 Kagoshima-shi Kagoshima Japan 890-0064
    76 Medical Corporation Seijinkai Ikeda Hospital /ID# 242174 Kanoya-shi Kagoshima Japan 893-0024
    77 Shonan Tobu Sogo Hospital /ID# 241913 CHIGASAKI-shi Kanagawa Japan 253-0083
    78 Shonan Kamakura General Hospital /ID# 243053 Kamakura-shi Kanagawa Japan 247-8533
    79 Teikyo University Hospital, Mizonokuchi /ID# 244842 Kawasaki City Kanagawa Japan 213-0002
    80 Kawasaki Municipal Hospital /ID# 241162 Kawasaki-shi Kanagawa Japan 2100013
    81 Kanagawa Cancer Center /ID# 246822 Yokohama-shi Kanagawa Japan 241-8515
    82 Kochi Health Sciences Center /ID# 241182 高知市 Kochi Japan 781-0111
    83 Kumamoto University Hospital /ID# 239720 Kumamoto shi Kumamoto Japan 8608556
    84 National Hospital Organization Kumamoto Medical Center /ID# 240886 Kumamoto-shi Kumamoto Japan 860-0008
    85 Kumamoto Shinto General Hospital /ID# 242176 Kumamoto-shi Kumamoto Japan 862-8655
    86 Kumamoto Minami National Hospital /ID# 242169 Uki Kumamoto Japan 869-0524
    87 University Hospital Kyoto Prefectural University of Medicine /ID# 244843 Kyoto-shi Kyoto Japan 602-8566
    88 JCHO Kyoto Kuramaguchi Medical /ID# 248775 Kyoto-shi Kyoto Japan 603-8151
    89 Kyoto University Hospital /ID# 244844 Kyoto-shi Kyoto Japan 606-8507
    90 National Hospital Organization Kyoto Medical Center /ID# 239092 Kyoto-shi Kyoto Japan 612-8555
    91 Uji Tokushukai Medical Center /ID# 241876 Uji-shi Kyoto Japan 611-0042
    92 Takeuchi Hospital /ID# 238750 津市 Mie Japan 514-0031
    93 Miyagi Cancer Center /ID# 241879 Natori-shi Miyagi Japan 981-1293
    94 Tohoku University Hospital /ID# 243757 Sendai-shi Miyagi Japan 9808574
    95 National Hospital Organization Sendai Medical Center /ID# 239384 Sendai-shi Miyagi Japan 983-8520
    96 Koga General Hospital /ID# 248120 Miyazaki-shi Miyazaki Japan 8800041
    97 Nagasaki Goto Chuoh Hospital /ID# 239723 Goto-shi Nagasaki Japan 853-0031
    98 Jap Red Cross Nagasaki Genbaku /ID# 245029 Nagasaki-shi Nagasaki Japan 852-8104
    99 Nagasaki University Hospital /ID# 245028 Nagasaki-shi Nagasaki Japan 852-8501
    100 NHO Nagasaki Medical Center /ID# 240571 Omura-shi Nagasaki Japan 856-8562
    101 Sasebo City General Hospital /ID# 238759 Sasebo-shi Nagasaki Japan 857-0056
    102 Niigata University Medical & Dental Hospital /ID# 245027 Niigata-shi Niigata Japan 951-8520
    103 Almeida Memorial Hospital /ID# 241916 Oita City Oita Japan 870-1133
    104 Oita Memorial Hospital /ID# 246818 Oita-shi Oita Japan 870-0854
    105 Oita Prefectural Hospital /ID# 243786 Oita-shi Oita Japan 870-0855
    106 Kawasaki Medical School Hospital /ID# 242709 Kurashiki-shi Okayama Japan 701-0192
    107 Kurashiki Central Hospital /ID# 244205 Kurashiki-shi Okayama Japan 710-8602
    108 Kaneda Hospital /ID# 238757 Maniwa Okayama Japan 719-3105
    109 Okayama University Hospital /ID# 240887 Okayama-shi Okayama Japan 700-8558
    110 Okayama University Hospital /ID# 243755 Okayama-shi Okayama Japan 700-8558
    111 Japanese Red Cross Okayama Hospital /ID# 240879 Okayama-shi Okayama Japan 700-8607
    112 Okayama Medical Center /ID# 243759 Okayama-shi Okayama Japan 701-1192
    113 Naha City Hospital /ID# 242027 Naha-shi Okinawa Japan 902-8511
    114 University of the Ryukyus Hospital /ID# 246821 Nakagami-gun Okinawa Japan 903-0215
    115 Nakagami Hospital /ID# 243787 Okinawa-shi Okinawa Japan 904-2195
    116 Shiroyama Hospital /ID# 246762 Habikino-shi Osaka Japan 583-0872
    117 Kansai Medical University Hospital /ID# 246820 Hirakata-shi Osaka Japan 573-1191
    118 Kishiwada City Hospital /ID# 234002 Kishiwada-shi Osaka Japan 596-8501
    119 Sumitomo Hospital /ID# 243774 Kita-ku Osaka Japan 530-0005
    120 Osaka City General Hospital /ID# 244210 Osaka-shi Osaka Japan 534-0021
    121 National Hospital Organization Osaka National Hospital /ID# 238764 Osaka-shi Osaka Japan 540-0006
    122 Japanese Red Cross Osaka Hospi /ID# 248784 Osaka-shi Osaka Japan 543-8555
    123 Daini Osaka Police Hospital /ID# 240560 Osaka-shi Osaka Japan 543-8922
    124 Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 243783 Osaka-shi Osaka Japan 550-0006
    125 Ishikiriseiki Hospital /ID# 246077 東大阪市 Osaka Japan 579-8026
    126 Saga Medical Center Koseikan /ID# 245816 Saga-shi Saga Japan 840-8571
    127 TMG Asaka Medical Center /ID# 238761 Asaka-shi Saitama Japan 351-0023
    128 NHO Saitama National Hospital /ID# 245061 Wako-shi Saitama Japan 351-0102
    129 Saiseikai Shiga Hospital /ID# 239381 Ritto Shiga Japan 520-3046
    130 Shimane Prefectural Central Ho /ID# 247895 Izumo-shi Shimane Japan 693-8555
    131 Shizuoka Saiseikai Genaral Hospital /ID# 239722 Shizuoka-shi Shizuoka Japan 422-8527
    132 Dokkyo Medical University Hospital /ID# 246764 Shimotsuga-gun Tochigi Japan 321-0293
    133 Ishibashi General Hospital /ID# 243762 Shimotsuke City Tochigi Japan 329-0502
    134 Tochigi Cancer Center /ID# 249445 Utsunomiya-shi Tochigi Japan 320-0834
    135 Anan Medical Center /ID# 243781 Anan-shi Tokushima Japan 774-0045
    136 Tokushima Prefecture Naruto Hospital /ID# 239095 Naruto-shi Tokushima Japan 772-0001
    137 Juntendo University Hospital /ID# 239096 Bunkyo-ku Tokyo Japan 113-8431
    138 Tokyo Medical And Dental University Hospital /ID# 242178 Bunkyo-ku Tokyo Japan 113-8519
    139 Medical Plaza Edogawa /ID# 244220 Edogawa Ward Tokyo Japan 133-0052
    140 Edogawa Hospital /ID# 239352 Edogawa-ku Tokyo Japan 133-0052
    141 Fussa Hospital /ID# 240570 Fussa Tokyo Japan 1970012
    142 Tama-Hokubu Medical Center /ID# 245879 Higashimurayama-shi Tokyo Japan 189-8511
    143 The Cancer Institute Hospital Of JFCR /ID# 244216 Koto-ku Tokyo Japan 135-8550
    144 Mishuku Hospital /ID# 239378 Meguro-ku Tokyo Japan 153-0051
    145 Kyorin University Hospital /ID# 243777 Mitaka-shi Tokyo Japan 181-8611
    146 Japanese Red Cross Musashino Hospital /ID# 246765 Musashino-shi Tokyo Japan 180-8610
    147 Metropolitan Research and Treatment Center for Blood Disorders /ID# 231384 Setagaya Ward Tokyo Japan 156-0052
    148 National Center for Child Health and Development /ID# 243778 Setagaya-ku Tokyo Japan 157-8535
    149 Japanese Red Cross Medical Center /ID# 239385 Shibuya-ku Tokyo Japan 150-8935
    150 NTT Medical Center Tokyo /ID# 240566 Shinagawa-ku Tokyo Japan 141-8625
    151 Tokyo Metropolitan Bokutoh Hosital /ID# 241912 Sumida-ku Tokyo Japan 130-8575
    152 Eiju General Hospital /ID# 243763 Taito Tokyo Japan 110-0015
    153 Toshima Hospital /ID# 240878 板橋区 Tokyo Japan 173-0015
    154 Hiroshima-Nishi Medical Center /ID# 238766 Otake-shi Tottori Japan 739-0651
    155 Tottori Prefectural Central Ho /ID# 245877 Tottori-shi Tottori Japan 680-0901
    156 Yonago Medical Center /ID# 240572 Yonago-shi Tottori Japan 683-0006
    157 Tottori University Hospital /ID# 244215 Yonago-shi Tottori Japan 683-8504
    158 Kainan Medical Center /ID# 240825 海南市 Wakayama Japan 642-0002
    159 Okitama Public General Hospital /ID# 242710 Higashiokitama-gun Yamagata Japan 992-0601
    160 Yamagata University Hospital /ID# 246763 Yamagata-shi Yamagata Japan 990-9585
    161 NHO Iwakuni Clinical Center /ID# 242170 Iwakuni-shi Yamaguchi Japan 740-8510
    162 Tokuyama Central Hospital /ID# 242380 Shunan-shi Yamaguchi Japan 745-8522
    163 Yamaguchi University Hospital /ID# 245060 Ube-shi Yamaguchi Japan 755-8505
    164 Ogori Daiichi General Hospital /ID# 246761 Yamaguchi City Yamaguchi Japan 754-0002
    165 University of Yamanashi Hospital /ID# 246006 Chuo-shi Yamanashi Japan 409-3821
    166 Inoue Memorial Hospital /ID# 239351 Chiba Japan 260-0027
    167 Fujisawa City Hospital /ID# 239375 Fujisawa-shi Japan 251-8550
    168 Harasanshin Hospital /ID# 240881 Fukuoka-shi Japan 812-0033
    169 Kawaguchi Municipal Medical Center /ID# 246080 Kawaguchi-shi Japan 333-0833
    170 Kitakyusyu General Hospital /ID# 244212 Kitakyushu-shi Japan 800-0257
    171 Nankai Medical Center /ID# 241914 Saiki-shi Japan 876-0857
    172 Saitama City Hospital /ID# 240567 Saitama Japan 336-8522
    173 Nihonkai General Hospital /ID# 242024 Sakata-shi Japan 998-0828
    174 Tachikawa Hospital /ID# 245878 Tachikawa Japan
    175 Toyama Hospital /ID# 243779 Toyama Japan 939-8511

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04813263
    Other Study ID Numbers:
    • P20-408
    First Posted:
    Mar 24, 2021
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2022