Trial Outcomes & Findings for Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia (NCT NCT02677324)

Last Updated: 2022-05-11

Results Overview

Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

2 years

Results posted on

2022-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	ABT199 ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Overall Study STARTED	33
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	ABT199 ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Overall Study Disease Progression	6
Overall Study Inability to Swallow pills	1
Overall Study Non-compliance	1
Overall Study Lack of Efficacy	1
Overall Study Medical insurance coverage	1
Overall Study Adverse Event	1
Overall Study IgM Myeloma diagnosis	1

Baseline Characteristics

Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT199 n=33 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants
MYD88 Mutation	32 Participants n=5 Participants
CXCR4 Mutation	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.

Outcome measures

Outcome measures
Measure	ABT199 n=32 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Overall Response Rate	26 Participants

SECONDARY outcome

Timeframe: 2 years

Number of participants who experienced an adverse event while on ABT-199

Outcome measures

Outcome measures
Measure	ABT199 n=33 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	33 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.

A complete response is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.

Outcome measures

Outcome measures
Measure	ABT199 n=32 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Number of Participants With Complete Response	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.

Very Good Partial Response (VGPR): is defined as ≥90% reduction in serum IgM levels, or normalization of serum IgM levels.

Outcome measures

Outcome measures
Measure	ABT199 n=32 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Number of Participants With Very Good Partial Response	6 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.

Partial response (PR) is defined as achieving a ≥50% reduction in serum IgM levels.

Outcome measures

Outcome measures
Measure	ABT199 n=32 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Number of Participants With Partial Response	19 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.

Minor Response (MR): A minor response (MR) is defined 25-49% reduction in serum IgM levels.

Outcome measures

Outcome measures
Measure	ABT199 n=32 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Number of Participants With Minor Response	1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.

Stable disease is defined as having \<25% increase in serum IgM levels and \<25% reduction in serum IgM levels

Outcome measures

Outcome measures
Measure	ABT199 n=32 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Number of Participants With Stable Disease	2 Participants

SECONDARY outcome

Timeframe: 4 years

Population: 1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.

Amount of time following ABT-199 administration until \>25% increase in serum IgM

Outcome measures

Outcome measures
Measure	ABT199 n=32 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Progression Free Survival	31.5 months Interval 26.6 to 38.6

SECONDARY outcome

Timeframe: 2 years

Overall Response Rate for participants who tested positive for a CXCR4 mutation= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).

Outcome measures

Outcome measures
Measure	ABT199 n=17 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Overall Response Rate Among CXCR4 Mutated Participants	14 Participants

SECONDARY outcome

Timeframe: 2 years

Overall Response Rate in participants who tested negative for a CXCR4 mutation= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).

Outcome measures

Outcome measures
Measure	ABT199 n=15 Participants ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Overall Response Rate Among Participants Without CXCR4 Mutations	13 Participants

Adverse Events

ABT199

Serious events: 13 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABT199 n=33 participants at risk ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
Infections and infestations Upper Respiratory Infection	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Blood and lymphatic system disorders Febrile neutropenia	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Infections and infestations Sepsis due to Pneumonia	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Infections and infestations Soft tissue infection	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Infections and infestations Pneumonia	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Injury, poisoning and procedural complications Fracture	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Injury, poisoning and procedural complications Hip fracture	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Hyperuricemia	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Laboratory tumor lysis syndrome	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Nervous system disorders Syncope	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Renal and urinary disorders Renal calculi	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Hyperkalemia	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Rectal bleeding	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Infections and infestations Appendicitis	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Infections and infestations Influenza	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Abdominal pain	3.0% 1/33 • Number of events 1 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.

Other adverse events

Other adverse events
Measure	ABT199 n=33 participants at risk ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
General disorders Fatigue	69.7% 23/33 • Number of events 23 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
General disorders Fever	24.2% 8/33 • Number of events 8 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
General disorders Pain	18.2% 6/33 • Number of events 6 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
General disorders Edema limbs	15.2% 5/33 • Number of events 5 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Musculoskeletal and connective tissue disorders Myalgia	27.3% 9/33 • Number of events 9 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
General disorders Non-cardiac chest pain	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
General disorders Chills	9.1% 3/33 • Number of events 3 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
General disorders Dizziness	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 11/33 • Number of events 11 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Infections and infestations Upper respiratory infection	45.5% 15/33 • Number of events 15 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Infections and infestations Sinusitis	18.2% 6/33 • Number of events 6 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Infections and infestations Urinary tract infection	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Skin and subcutaneous tissue disorders Rash not otherwise specified	30.3% 10/33 • Number of events 10 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Injury, poisoning and procedural complications Bruising	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Injury, poisoning and procedural complications Fracture	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Investigations Neutrophil count decreased	66.7% 22/33 • Number of events 22 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Investigations Platelet count decreased	39.4% 13/33 • Number of events 13 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Investigations Lymphocyte count decreased	27.3% 9/33 • Number of events 9 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Investigations White blood cell decreased	24.2% 8/33 • Number of events 8 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Investigations Aspartate aminotransferase increased	15.2% 5/33 • Number of events 5 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Investigations Weight loss	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Investigations Alkaline phosphatase increased	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Hyperglycemia	21.2% 7/33 • Number of events 7 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Hypoalbuminemia	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Hypocalcemia	9.1% 3/33 • Number of events 3 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Anorexia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Hyperuricemia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Hypomagnesemia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Metabolism and nutrition disorders Hyponatremia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	18.2% 6/33 • Number of events 6 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Musculoskeletal and connective tissue disorders Pain in extremity	18.2% 6/33 • Number of events 6 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Musculoskeletal and connective tissue disorders Arthralgia	15.2% 5/33 • Number of events 5 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Musculoskeletal and connective tissue disorders Bone pain	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Musculoskeletal and connective tissue disorders Back pain	9.1% 3/33 • Number of events 3 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Musculoskeletal and connective tissue disorders Flank pain	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Musculoskeletal and connective tissue disorders Neck pain	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Nervous system disorders Peripheral sensory neuropathy	27.3% 9/33 • Number of events 9 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Nervous system disorders Dizziness	24.2% 8/33 • Number of events 8 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Nervous system disorders Headache	21.2% 7/33 • Number of events 7 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Nervous system disorders Paresthesia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Psychiatric disorders Anxiety	24.2% 8/33 • Number of events 8 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Psychiatric disorders Depression	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Psychiatric disorders Insomnia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Renal and urinary disorders Acute kidney injury	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	45.5% 15/33 • Number of events 15 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Cough	36.4% 12/33 • Number of events 12 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Postnasal drip	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Sore throat	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Skin and subcutaneous tissue disorders Pruritis	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Skin and subcutaneous tissue disorders Alopecia	9.1% 3/33 • Number of events 3 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 3/33 • Number of events 3 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Vascular disorders Hypertension	15.2% 5/33 • Number of events 5 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Vascular disorders Hypotension	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Blood and lymphatic system disorders Anemia	54.5% 18/33 • Number of events 18 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Cardiac disorders Palpitations	15.2% 5/33 • Number of events 5 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Cardiac disorders Sinus bradycardia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Cardiac disorders Sinus tachycardia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Cardiac disorders Ventricular arrhythmia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Ear and labyrinth disorders Tinnitus	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Eye disorders Blurred vision	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Diarrhea	60.6% 20/33 • Number of events 20 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Nausea	45.5% 15/33 • Number of events 15 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Constipation	24.2% 8/33 • Number of events 8 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Abdominal pain	21.2% 7/33 • Number of events 7 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Gastroesophageal reflux disease	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Vomiting	12.1% 4/33 • Number of events 4 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Bloating	9.1% 3/33 • Number of events 3 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Flatulence	9.1% 3/33 • Number of events 3 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Mucositis oral	9.1% 3/33 • Number of events 3 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Abdominal distension	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.
Gastrointestinal disorders Dyspepsia	6.1% 2/33 • Number of events 2 • Adverse events were collected from starting ABT-199, through study therapy, and up to 30 days after the last dose of ABT-199, for up to 2.5 years.

Additional Information

Jorge J. Castillo

DFCI

Phone: 617-632-2681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place