Trial Outcomes & Findings for A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL) (NCT NCT02588651)

Last Updated: 2025-11-21

Results Overview

The primary objective is to evaluate overall response rate (ORR). Overall response rate will be estimated by the total number of patients who achieve a CR and PR divided by the total number of patients who received treatment. Response was assessed using CT scans according to the revised Cheson criteria. * CR is defined as complete resolution of all clinically detectable disease and disease related symptoms that were present prior to therapy * PR is defined as at least 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses Patients should have completed at least 1 cycle of treatment to be evaluable for ORR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Three years after end of treatment, up to 49 months

Results posted on

2025-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Overall Study STARTED	23
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2
Overall Study Death	1
Overall Study Lack of Efficacy	13
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	1
Overall Study Disease progression	2

Baseline Characteristics

A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximab Vedotin n=23 Participants Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Age, Customized 20-29	3 years n=68 Participants
Age, Customized 40-49	2 years n=68 Participants
Age, Customized 50-59	3 years n=68 Participants
Age, Customized 60-69	9 years n=68 Participants
Age, Customized 70-79	4 years n=68 Participants
Age, Customized Unknown	2 years n=68 Participants
Sex: Female, Male Female	8 Participants n=68 Participants
Sex: Female, Male Male	15 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=68 Participants
Race (NIH/OMB) Asian	0 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants
Race (NIH/OMB) Black or African American	6 Participants n=68 Participants
Race (NIH/OMB) White	16 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants

PRIMARY outcome

Timeframe: Three years after end of treatment, up to 49 months

Population: 1 participant did not complete one cycle; 3 additional participants did not have response data

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=19 Participants Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Overall Response Rate	89.5 percentage of participants Interval 75.5 to 100.0

SECONDARY outcome

Timeframe: Three years after end of treatment, up to 49 months

Population: 1 participant did not complete one cycle; 3 additional participants did not have response data

Complete Response is defined as complete resolution of all clinically detectable disease and disease related symptoms that were present prior to therapy. A post-treatment residual mass of any size is permitted as long as it is PET negative. CR rate was calculated by dividing the total number of patients who have achieved a complete response by the total number of patients who received treatment.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=19 Participants Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Complete Response	10.5 percentage of participants Interval 0.0 to 24.3

SECONDARY outcome

Timeframe: Three years after end of treatment, up to 49 months

Population: 1 participant did not have at least one dose

Progression-free survival (PFS) is defined as the time from treatment initiation into the study to disease progression or death due to any cause. The distribution of PFS will be estimated using the Kaplan-Meier method. Disease progression may be defined as the date of documentation of a new lesion or enlargement of a previous lesion, or the date of the scheduled clinic visit immediately after radiologic assessment has been completed. For a patient who is alive without progression at the end of study follow-up, observation of PFS is censored on the date of last contact.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=22 Participants Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Progression Free Survival	8.0 Month Interval 5.3 to 12.3

SECONDARY outcome

Timeframe: Three years after end of treatment, up to 49 months

Population: 1 participant did not have at least one dose

The overall survival (OS) is defined as the time from treatment initiation to the time of death due to any cause. For a patient who is alive at the end of study follow-up, observation of OS is censored on the date of last contact. The distribution of OS will be estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=22 Participants Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Overall Survival	10.8 Month Interval 5.6 to 20.8

SECONDARY outcome

Timeframe: Three years after end of treatment, up to 49 months

Population: 6 participants did not have ORR

Duration of response (DOR) among responders is defined as the time from first documentation of objective tumor response (CR or PR) to the time of first progression or death due to any cause.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=17 Participants Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Duration of Response	5.4 Month Interval 2.8 to 17.6

SECONDARY outcome

Timeframe: Up to 13 months after start of treatment

Population: 6 participants did not have progression at last follow-up

Time to treatment failure (TTF) is defined as the time from treatment initiation to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. Date of last follow-up was collected for patients who did not have disease progression, but it is unknown for which reasons treatment was stopped for these patients. In this case, time to treatment failure (TTF) is the same as time to progression.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=17 Participants Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Time to Treatment Failure (TTF)	7.4 Month Interval 5.1 to 12.1

SECONDARY outcome

Timeframe: Three years after end of treatment, up to 49 months

Population: 6 participants did not have ORR

Time to treatment failure (TTR) is defined as time from treatment initiation to first documentation of objective tumor response (CR or PR).

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=17 Participants Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Time to Response (TTR)	2.7 Month Interval 2.5 to 2.7

Adverse Events

Brentuximab Vedotin

Serious events: 10 serious events

Other events: 23 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Brentuximab Vedotin n=23 participants at risk Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Blood and lymphatic system disorders Anemia	4.3% 1/23 • Number of events 1 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Blood bilirubin increased	4.3% 1/23 • Number of events 1 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • Number of events 2 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Vascular disorders Capillary leak syndrome	4.3% 1/23 • Number of events 2 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 1/23 • Number of events 2 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
General disorders Fever	17.4% 4/23 • Number of events 8 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
General disorders Fatigue	4.3% 1/23 • Number of events 2 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	4.3% 1/23 • Number of events 2 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hypercalcemia	4.3% 1/23 • Number of events 1 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hyponatremia	4.3% 1/23 • Number of events 3 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Infections and infestations - Other, specify -	4.3% 1/23 • Number of events 1 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Renal and urinary disorders Kidney infection	4.3% 1/23 • Number of events 2 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Lung infection	4.3% 1/23 • Number of events 2 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Mucositis oral	4.3% 1/23 • Number of events 1 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	4.3% 1/23 • Number of events 1 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Neutrophil count decreased	8.7% 2/23 • Number of events 5 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.3% 1/23 • Number of events 2 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Vascular disorders Thromboembolic event	4.3% 1/23 • Number of events 2 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.

Other adverse events

Other adverse events
Measure	Brentuximab Vedotin n=23 participants at risk Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks Brentuximab vedotin: study drug given intravenously to determine efficacy in study diseases
Gastrointestinal disorders Abdominal pain	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Renal and urinary disorders Acute kidney injury	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Alanine aminotransferase increased	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Alkaline phosphatase increased	30.4% 7/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Immune system disorders Allergic reaction	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Skin and subcutaneous tissue disorders Alopecia	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Blood and lymphatic system disorders Anemia	39.1% 9/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Anorexia	39.1% 9/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Psychiatric disorders Anxiety	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Aspartate aminotransferase increased	17.4% 4/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Atelectasis	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Musculoskeletal and connective tissue disorders Back Pain	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Bloating	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Blood bilirubin increased	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Musculoskeletal and connective tissue disorders Bone pain	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Vascular disorders Capillary leak syndrome	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
General disorders Chills	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Psychiatric disorders Confusion	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Constipation	30.4% 7/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Cough	17.4% 4/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Creatinine increased	26.1% 6/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Diarrhea	26.1% 6/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Nervous system disorders Dizziness	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Dry mouth	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Skin and subcutaneous tissue disorders Dry skin	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Nervous system disorders Dysgeusia	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
General disorders Edema face	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Reproductive system and breast disorders Erectile dysfunction	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Injury, poisoning and procedural complications Fall	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
General disorders Fatigue	43.5% 10/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
General disorders Fever	34.8% 8/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
General disorders Flu like symptoms	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Musculoskeletal and connective tissue disorders Flank pain	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Gastroesophageal reflux disease	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
General disorders Edema	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	17.4% 4/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Reproductive system and breast disorders Genital edema	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Reproductive system and breast disorders Gynecomastia	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Ear and labyrinth disorders Hearing impaired	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Hepatobiliary disorders Portal hypertension	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hypercalcemia	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hyperglycemia	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hypermagnesemia	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hypoalbuminemia	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hypocalcemia	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hypokalemia	21.7% 5/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hypomagnesemia	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Hyponatremia	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Nervous system disorders Headache	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Vascular disorders Hypertension	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Vascular disorders Hypotension	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Mucositis oral	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Blood and lymphatic system disorders Lymph node pain	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Infections and infestations Lung infection	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Lymphocyte count decreased	21.7% 5/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Nausea	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Infections and infestations Nail infection	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations Neutrophil count decreased	30.4% 7/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Blood and lymphatic system disorders Platelet count decreased	26.1% 6/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Infections and infestations Papulopustular rash	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Nervous system disorders Paresthesia	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Nervous system disorders Peripheral motor neuropathy	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Nervous system disorders Peripheral sensory neuropathy	39.1% 9/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Nervous system disorders Presyncope	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Skin and subcutaneous tissue disorders Pruritus	21.7% 5/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	13.0% 3/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Infections and infestations Infections and infestations - Other, specify	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations INR increased	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Psychiatric disorders Insomnia	17.4% 4/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Cardiac disorders Sinus tachycardia	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Infections and infestations Sinusitis	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Infections and infestations Soft tissue infection	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Reproductive system and breast disorders Scrotal pain	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Ear and labyrinth disorders Tinnitus	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Infections and infestations Thrush	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Infections and infestations Upper respiratory infection	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Infections and infestations Urinary tract infection	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Renal and urinary disorders Urinary frequency	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Renal and urinary disorders Urinary urgency	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Gastrointestinal disorders Vomiting	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Investigations White blood cell decreased	8.7% 2/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.
Metabolism and nutrition disorders Weight loss	4.3% 1/23 • All AEs (regardless of relationship to study drug) captured from the time the subject signs the ICF through the end of the safety-reporting period, approximately 4 years.

Additional Information

Study Principal Investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Phone: 1-866-223-8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place