Trial Outcomes & Findings for Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma (NCT NCT01534078)

Last Updated: 2018-02-20

Results Overview

Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

End of Therapy (median duration of four months)

Results posted on

2018-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine (AVD) Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine (AVD) Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Overall Study Death	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Information is missing for one participant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=34 Participants Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Age, Continuous	36 years n=34 Participants
Age, Customized 20 - 30 years	10 Participants n=34 Participants
Age, Customized 31 - 40 years	9 Participants n=34 Participants
Age, Customized 41 - 60 years	10 Participants n=34 Participants
Age, Customized 61 - 75 years	5 Participants n=34 Participants
Sex: Female, Male Female	17 Participants n=34 Participants
Sex: Female, Male Male	17 Participants n=34 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=34 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=34 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=34 Participants
Race/Ethnicity, Customized More Than One Race	1 Participants n=34 Participants
Race/Ethnicity, Customized Other	7 Participants n=34 Participants
Race/Ethnicity, Customized White	26 Participants n=34 Participants
Region of Enrollment United States	34 participants n=34 Participants
Stage IA	6 Participants n=34 Participants
Stage IIA	24 Participants n=34 Participants
Stage IIB	4 Participants n=34 Participants
Cellularity Hypercellular	1 Participants n=34 Participants
Cellularity Hypocellular	4 Participants n=34 Participants
Cellularity Normocellular	10 Participants n=34 Participants
Cellularity Missing	19 Participants n=34 Participants
Histology Classical Hodgkin Lymphoma, NOS	8 Participants n=34 Participants
Histology Lymphocytic Rich	4 Participants n=34 Participants
Histology Mixed Cellularity	4 Participants n=34 Participants
Histology Nodular Sclerosis	18 Participants n=34 Participants
Risk Class Early Favorable	21 Participants n=34 Participants
Risk Class Early Unfavorable	13 Participants n=34 Participants
Number of Lesions	5 Lesions n=33 Participants • Information is missing for one participant
Longest Tumor Diameter	33.4 Centimeters (cm) n=33 Participants • Information is missing for one participant

PRIMARY outcome

Timeframe: End of Therapy (median duration of four months)

Population: Two participants were not evaluated for response due to a death and a withdrawal.

Outcome measures

Outcome measures
Measure	Treatment Arm n=32 Participants Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Complete Response Rate	31 Participants

SECONDARY outcome

Timeframe: 28 days

The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria. * CR: Disappearance of all evidence of disease * PR: Regression of measurable disease and no new sites

Outcome measures

Outcome measures
Measure	Treatment Arm n=34 Participants Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Overall Response Rate After One Cycle of Brentuximab	18 Participants

SECONDARY outcome

Timeframe: End of Therapy (median duration of four months)

Population: Two participants were not evaluated for response due to a death and a withdrawal.

The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria. * CR: Disappearance of all evidence of disease * PR: Regression of measurable disease and no new sites

Outcome measures

Outcome measures
Measure	Treatment Arm n=32 Participants Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Overall Response Rate Complete Response	31 Participants
Overall Response Rate Partial Response	0 Participants

SECONDARY outcome

Timeframe: 2 years

A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.

Outcome measures

Outcome measures
Measure	Treatment Arm n=34 Participants Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Grade III or IV Adverse Events Neutrophil count decreased	21 participants
Grade III or IV Adverse Events Fatigue	3 participants
Grade III or IV Adverse Events Nausea	1 participants
Grade III or IV Adverse Events Peripheral sensory neuropathy	8 participants
Grade III or IV Adverse Events Anemia	2 participants
Grade III or IV Adverse Events White blood cell decreased	6 participants
Grade III or IV Adverse Events Abdominal pain	2 participants
Grade III or IV Adverse Events Diarrhea	1 participants
Grade III or IV Adverse Events Febrile neutropenia	12 participants
Grade III or IV Adverse Events Vomiting	1 participants
Grade III or IV Adverse Events Mucositis oral	1 participants
Grade III or IV Adverse Events Weight loss	2 participants
Grade III or IV Adverse Events Dehydration	1 participants
Grade III or IV Adverse Events Hypertension	1 participants
Grade III or IV Adverse Events Infections and infestations - Other, specify	1 participants
Grade III or IV Adverse Events Blood and lymphatic system disorders - Other, spec	1 participants

Adverse Events

Treatment Arm

Serious events: 15 serious events

Other events: 34 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm n=34 participants at risk Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Metabolism and nutrition disorders Dehydration	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
General disorders Fever	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Gastric Hemorrhage	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Skin and subcutaneous tissue disorders Hidradenitis Suppurativa	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Ileus	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Infections and infestations Line Infection	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Nausea, Vomiting, Dehydration	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Infections and infestations Soft Tissue Infection	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Metabolism and nutrition disorders Anorexia, Fatigue	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Respiratory, thoracic and mediastinal disorders Aspiration	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Blood and lymphatic system disorders Febrile Neutropenia	23.5% 8/34 • Number of events 8 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations Neutrophil Count Decreased	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Infections and infestations Sepsis	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations White Blood Cell Decreased	2.9% 1/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Viral Gastritis	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Abdominal Pain	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Infections and infestations Bronchial Infection	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Cardiac disorders Chest Pain - Cardiac	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Psychiatric disorders Confusion	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Musculoskeletal and connective tissue disorders Hip pain, back pain	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Anorexia, Nausea, Vomiting	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Diarrhea, Hypotension	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
General disorders Fever, Sinus Congestion	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Ileus, Esophagitis, Transaminase elevation, low white blood cell count, dehydration	2.9% 1/34 • Number of events 1 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.

Other adverse events

Other adverse events
Measure	Treatment Arm n=34 participants at risk Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine Brentuximab Vedotin: 2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg Adriamycin, vinblastine, and dacarbazine: Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Ear and labyrinth disorders Tinnitus	14.7% 5/34 • Number of events 5 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Blood and lymphatic system disorders Anemia	79.4% 27/34 • Number of events 52 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Blood and lymphatic system disorders Febrile neutropenia	17.6% 6/34 • Number of events 6 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Blood and lymphatic system disorders Leukocytosis	8.8% 3/34 • Number of events 5 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Cardiac disorders Sinus tachycardia	5.9% 2/34 • Number of events 4 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
General disorders Edema limbs	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
General disorders Fatigue	88.2% 30/34 • Number of events 53 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
General disorders Fever	11.8% 4/34 • Number of events 6 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
General disorders Infusion related reaction	8.8% 3/34 • Number of events 5 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
General disorders Malaise	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
General disorders Pain	23.5% 8/34 • Number of events 14 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
General disorders General disorders and administration site conditions - Other,	8.8% 3/34 • Number of events 4 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Skin and subcutaneous tissue disorders Alopecia	47.1% 16/34 • Number of events 21 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Skin and subcutaneous tissue disorders Erythema multiforme	5.9% 2/34 • Number of events 3 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Skin and subcutaneous tissue disorders Hyperhidrosis	17.6% 6/34 • Number of events 6 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Skin and subcutaneous tissue disorders Pruritus	20.6% 7/34 • Number of events 8 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Skin and subcutaneous tissue disorders Rash acneiform	14.7% 5/34 • Number of events 6 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Skin and subcutaneous tissue disorders Rash maculo-papular	23.5% 8/34 • Number of events 9 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	23.5% 8/34 • Number of events 12 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Endocrine disorders Endocrine disorders - Other, specify	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Abdominal pain	41.2% 14/34 • Number of events 24 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Bloating	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Colitis	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Constipation	76.5% 26/34 • Number of events 35 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Diarrhea	44.1% 15/34 • Number of events 25 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Dry mouth	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Gastritis	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Gastroesophageal reflux disease	20.6% 7/34 • Number of events 8 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Hemorrhoids	11.8% 4/34 • Number of events 4 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Mucositis oral	23.5% 8/34 • Number of events 8 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Nausea	76.5% 26/34 • Number of events 41 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Oral pain	11.8% 4/34 • Number of events 4 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Rectal hemorrhage	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Vomiting	35.3% 12/34 • Number of events 18 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	14.7% 5/34 • Number of events 8 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Infections and infestations Upper respiratory infection	14.7% 5/34 • Number of events 7 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Infections and infestations Urinary tract infection	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Infections and infestations Infections and infestations - Other, specify	11.8% 4/34 • Number of events 6 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations Alanine aminotransferase increased	41.2% 14/34 • Number of events 21 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations Alkaline phosphatase increased	5.9% 2/34 • Number of events 3 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations Aspartate aminotransferase increased	29.4% 10/34 • Number of events 14 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations Neutrophil count decreased	76.5% 26/34 • Number of events 74 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations Platelet count decreased	17.6% 6/34 • Number of events 10 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations Weight loss	20.6% 7/34 • Number of events 14 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations White blood cell decreased	61.8% 21/34 • Number of events 56 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Investigations Investigations - Other, specify	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Metabolism and nutrition disorders Anorexia	26.5% 9/34 • Number of events 11 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Metabolism and nutrition disorders Dehydration	14.7% 5/34 • Number of events 7 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Metabolism and nutrition disorders Hyperglycemia	41.2% 14/34 • Number of events 17 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Metabolism and nutrition disorders Hypokalemia	8.8% 3/34 • Number of events 3 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Musculoskeletal and connective tissue disorders Arthralgia	26.5% 9/34 • Number of events 12 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Musculoskeletal and connective tissue disorders Back pain	20.6% 7/34 • Number of events 7 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Musculoskeletal and connective tissue disorders Bone pain	41.2% 14/34 • Number of events 21 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	17.6% 6/34 • Number of events 6 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Musculoskeletal and connective tissue disorders Myalgia	17.6% 6/34 • Number of events 8 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Musculoskeletal and connective tissue disorders Pain in extremity	14.7% 5/34 • Number of events 8 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder -	26.5% 9/34 • Number of events 13 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Nervous system disorders Dizziness	26.5% 9/34 • Number of events 9 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Nervous system disorders Headache	26.5% 9/34 • Number of events 10 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Nervous system disorders Memory impairment	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Nervous system disorders Peripheral motor neuropathy	20.6% 7/34 • Number of events 11 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Nervous system disorders Peripheral sensory neuropathy	79.4% 27/34 • Number of events 67 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Nervous system disorders Nervous system disorders - Other, specify	8.8% 3/34 • Number of events 5 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Psychiatric disorders Anxiety	20.6% 7/34 • Number of events 8 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Psychiatric disorders Depression	11.8% 4/34 • Number of events 4 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Psychiatric disorders Insomnia	35.3% 12/34 • Number of events 14 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Psychiatric disorders Restlessness	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Respiratory, thoracic and mediastinal disorders Cough	23.5% 8/34 • Number of events 11 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.7% 5/34 • Number of events 5 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Respiratory, thoracic and mediastinal disorders Sore throat	8.8% 3/34 • Number of events 3 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	11.8% 4/34 • Number of events 4 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Vascular disorders Flushing	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Vascular disorders Hot flashes	8.8% 3/34 • Number of events 3 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Vascular disorders Hypertension	35.3% 12/34 • Number of events 31 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Vascular disorders Hypotension	5.9% 2/34 • Number of events 3 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.
Vascular disorders Thromboembolic event	5.9% 2/34 • Number of events 2 • From the start of therapy until the the end of followup due to disease progression, death, or withdrawal from the study. Median follow-up duration of 38 months. Adverse events were assessed with regularly scheduled physical exams, laboratory tests, and participant self reports.

Additional Information

Jeremy Abramson, MD

Massachusetts General Hospital

Phone: 617-724-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place