Trial Outcomes & Findings for Brentuximab Vedotin and Lenalidomide in Treating Patients With Stage IB-IVB Relapsed or Refractory T-Cell Lymphoma (NCT NCT03409432)
NCT ID: NCT03409432
Last Updated: 2026-08-13
Results Overview
The overall response rate (ORR) of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL. . ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR). Response (CR, PR, SD) and progression will be defined using the Global Response Score
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2026-08-13
Participant Flow
Participant milestones
| Measure |
Treatment (Brentuximab Vedotin, Lenalidomide)
Patients receive 1.2mg/kg brentuximab vedotin IV over 30 minutes on day 1 and 10mg/day lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Brentuximab Vedotin, Lenalidomide)
Patients receive 1.2mg/kg brentuximab vedotin IV over 30 minutes on day 1 and 10mg/day lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Number of prior therapies was unknown for 2 participants.
Baseline characteristics by cohort
| Measure |
Treatment (Brentuximab Vedotin, Lenalidomide)
n=26 Participants
Patients receive 1.2mg/kg brentuximab vedotin IV over 30 minutes on day 1 and 10mg/day lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
60 Years
n=26 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=26 Participants
|
|
Prior Therapies
|
4.5 Number of prior therapies
n=24 Participants • Number of prior therapies was unknown for 2 participants.
|
|
Histology and Stage
Mycosis fungoides (MF)
|
13 Participants
n=26 Participants
|
|
Histology and Stage
Peripheral T-cell lymphomas (PTCL)
|
8 Participants
n=26 Participants
|
|
Histology and Stage
Sezary syndrome (SS)
|
3 Participants
n=26 Participants
|
|
Histology and Stage
CD30+ lymphoproliferative disorders (LPD)
|
2 Participants
n=26 Participants
|
|
CD30 Positive
No
|
4 Participants
n=26 Participants
|
|
CD30 Positive
Yes
|
18 Participants
n=26 Participants
|
|
CD30 Positive
Unknown
|
4 Participants
n=26 Participants
|
|
Large cell transformation (only applicable to MF and SS)
No
|
7 Participants
n=16 Participants • Only applicable to MF and SS, n=16
|
|
Large cell transformation (only applicable to MF and SS)
Yes
|
5 Participants
n=16 Participants • Only applicable to MF and SS, n=16
|
|
Large cell transformation (only applicable to MF and SS)
Unknown
|
4 Participants
n=16 Participants • Only applicable to MF and SS, n=16
|
|
Baseline mSWAT (only applicable to MF, SS and LPD)
|
57 Score on a scale
n=18 Participants • Only applicable to MF, SS and LPD, n=18
|
|
Skindex (only applicable to MF, SS and LPD)
|
57 Score on a scale
n=18 Participants • Only applicable to MF, SS and LPD, n=18
|
PRIMARY outcome
Timeframe: Up to 2 yearsThe overall response rate (ORR) of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL. . ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR). Response (CR, PR, SD) and progression will be defined using the Global Response Score
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Lenalidomide)
n=26 Participants
Patients receive 1.2mg/kg brentuximab vedotin IV over 30 minutes on day 1 and 10mg/day lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
|
34.6 Percentage of participants
Interval 17.2 to 55.7
|
SECONDARY outcome
Timeframe: Up to 30 days after last day of study treatmentToxicity will be graded by the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Lenalidomide)
n=26 Participants
Patients receive 1.2mg/kg brentuximab vedotin IV over 30 minutes on day 1 and 10mg/day lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Fall
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Fracture
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Gait disturbance
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
White blood cell decreased
|
11 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Neutrophil count decreased
|
10 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Weight loss
|
3 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Dyspnea
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Diarrhea
|
14 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Lymphocyte count decreased
|
12 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Anemia
|
11 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Rash maculo-papular
|
10 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Fatigue
|
9 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Aspartate aminotransferase increased
|
8 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Nausea
|
8 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Peripheral sensory neuropathy
|
8 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Platelet count decreased
|
7 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Abdominal pain
|
6 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Constipation
|
6 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Edema limbs
|
6 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Myalgia
|
5 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Pruritus
|
5 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Alkaline phosphatase increased
|
4 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Anorexia
|
4 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Malaise
|
4 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Vomiting
|
4 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Alanine aminotransferase increased
|
3 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Dizziness
|
3 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Dysgeusia
|
3 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Gastrointestinal disorders - Other, specify
|
3 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Musculoskeletal and connective tissue disorder - Other, specify
|
3 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Skin and subcutaneous tissue disorders - Other, specify
|
3 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Blood bilirubin increased
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Fever
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hyperglycemia
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hypoalbuminemia
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hypokalemia
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hypomagnesemia
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hypothyroidism
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Infusion related reaction
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Pain
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Pain in extremity
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Skin hyperpigmentation
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Stomach pain
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Thromboembolic event
|
2 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Allergic rhinitis
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Alopecia
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Bloating
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Bruising
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
CD4 lymphocytes decreased
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Colitis
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Creatinine increased
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Depression
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Dyspepsia
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
General disorders and administration site conditions - Other, specify
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Generalized muscle weakness
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Headache
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hoarseness
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hot flashes
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hyperhidrosis
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hypocalcemia
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hypoglycemia
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Hypotension
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Immune system disorders - Other, specify
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Infections and infestations - Other, specify
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Lung infection
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Muscle weakness lower limb
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Paresthesia
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Portal vein thrombosis
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Respiratory, thoracic and mediastinal disorders - Other, specify
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Skin infection
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Skin ulceration
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Urinary tract infection
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Vertigo
|
1 Number of participants
|
|
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Weight gain
|
1 Number of participants
|
SECONDARY outcome
Timeframe: From start of study treatment to date of death due to any cause, assessed up to 2 yearsKaplan-Meier method will be used to estimate OS.
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Lenalidomide)
n=26 Participants
Patients receive 1.2mg/kg brentuximab vedotin IV over 30 minutes on day 1 and 10mg/day lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival (OS)
|
22.6 Months
Interval 11.7 to 42.8
|
SECONDARY outcome
Timeframe: From start of study treatment to first documentation of tumor progression (including radiographic and clinical progression) or to death due to any cause, whichever comes first, assessed up to 2 yearsKaplan-Meier method will be used to estimate PFS.
Outcome measures
| Measure |
Treatment (Brentuximab Vedotin, Lenalidomide)
n=26 Participants
Patients receive 1.2mg/kg brentuximab vedotin IV over 30 minutes on day 1 and 10mg/day lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression Free Survival (PFS)
|
6.7 Months
Interval 2.9 to 19.9
|
Adverse Events
Treatment (Brentuximab Vedotin, Lenalidomide)
Serious events: 7 serious events
Other events: 26 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Treatment (Brentuximab Vedotin, Lenalidomide)
n=26 participants at risk
Patients receive 1.2mg/kg brentuximab vedotin IV over 30 minutes on day 1 and 10mg/day lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Fever
|
3.8%
1/26 • Number of events 2 • Assessed up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Infections and infestations
Lung infection
|
3.8%
1/26 • Number of events 2 • Assessed up to 2 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Infections and infestations
Sepsis
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
Other adverse events
| Measure |
Treatment (Brentuximab Vedotin, Lenalidomide)
n=26 participants at risk
Patients receive 1.2mg/kg brentuximab vedotin IV over 30 minutes on day 1 and 10mg/day lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
15.4%
4/26 • Number of events 11 • Assessed up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
19.2%
5/26 • Number of events 7 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.8%
1/26 • Number of events 5 • Assessed up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
46.2%
12/26 • Number of events 28 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
19.2%
5/26 • Number of events 14 • Assessed up to 2 years
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
8/26 • Number of events 17 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Number of events 3 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
3.8%
1/26 • Number of events 3 • Assessed up to 2 years
|
|
Investigations
Blood bilirubin increased
|
11.5%
3/26 • Number of events 6 • Assessed up to 2 years
|
|
Eye disorders
Blurred vision
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Investigations
CD4 lymphocytes decreased
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Investigations
Cardiac troponin I increased
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Eye disorders
Cataract
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Chills
|
23.1%
6/26 • Number of events 7 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Colonic ulcer
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Eye disorders
Conjunctivitis
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
26.9%
7/26 • Number of events 10 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 4 • Assessed up to 2 years
|
|
Investigations
Creatinine increased
|
11.5%
3/26 • Number of events 5 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Psychiatric disorders
Depression
|
11.5%
3/26 • Number of events 6 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
53.8%
14/26 • Number of events 21 • Assessed up to 2 years
|
|
Nervous system disorders
Dizziness
|
15.4%
4/26 • Number of events 6 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.5%
3/26 • Number of events 5 • Assessed up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
11.5%
3/26 • Number of events 3 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
4/26 • Number of events 5 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Edema limbs
|
34.6%
9/26 • Number of events 15 • Assessed up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
19.2%
5/26 • Number of events 5 • Assessed up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
11.5%
3/26 • Number of events 4 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Fatigue
|
34.6%
9/26 • Number of events 17 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Fever
|
7.7%
2/26 • Number of events 3 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
2/26 • Number of events 7 • Assessed up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Gait disturbance
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
11.5%
3/26 • Number of events 6 • Assessed up to 2 years
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
|
7.7%
2/26 • Number of events 7 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
2/26 • Number of events 7 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • Number of events 4 • Assessed up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Vascular disorders
Hot flashes
|
11.5%
3/26 • Number of events 4 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
38.5%
10/26 • Number of events 28 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Vascular disorders
Hypertension
|
26.9%
7/26 • Number of events 19 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
38.5%
10/26 • Number of events 20 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
34.6%
9/26 • Number of events 22 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
6/26 • Number of events 14 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.1%
6/26 • Number of events 8 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
2/26 • Number of events 4 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.4%
4/26 • Number of events 7 • Assessed up to 2 years
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Number of events 5 • Assessed up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
11.5%
3/26 • Number of events 3 • Assessed up to 2 years
|
|
Investigations
INR increased
|
7.7%
2/26 • Number of events 3 • Assessed up to 2 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.8%
1/26 • Number of events 11 • Assessed up to 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Infusion related reaction
|
7.7%
2/26 • Number of events 3 • Assessed up to 2 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Psychiatric disorders
Insomnia
|
19.2%
5/26 • Number of events 5 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
3.8%
1/26 • Number of events 2 • Assessed up to 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Localized edema
|
3.8%
1/26 • Number of events 2 • Assessed up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
50.0%
13/26 • Number of events 37 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Malaise
|
15.4%
4/26 • Number of events 4 • Assessed up to 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
7.7%
2/26 • Number of events 6 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
15.4%
4/26 • Number of events 5 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.1%
6/26 • Number of events 12 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
34.6%
9/26 • Number of events 10 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
23.1%
6/26 • Number of events 9 • Assessed up to 2 years
|
|
Investigations
Neutrophil count decreased
|
38.5%
10/26 • Number of events 33 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
General disorders and administration site conditions
Pain
|
23.1%
6/26 • Number of events 13 • Assessed up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
2/26 • Number of events 6 • Assessed up to 2 years
|
|
Nervous system disorders
Paresthesia
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.8%
8/26 • Number of events 35 • Assessed up to 2 years
|
|
Investigations
Platelet count decreased
|
26.9%
7/26 • Number of events 14 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.4%
4/26 • Number of events 4 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.9%
7/26 • Number of events 8 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
38.5%
10/26 • Number of events 21 • Assessed up to 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.8%
1/26 • Number of events 3 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
7.7%
2/26 • Number of events 3 • Assessed up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Infections and infestations
Sinusitis
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
19.2%
5/26 • Number of events 7 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
11.5%
3/26 • Number of events 4 • Assessed up to 2 years
|
|
Infections and infestations
Skin infection
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.8%
1/26 • Number of events 2 • Assessed up to 2 years
|
|
Nervous system disorders
Somnolence
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Stomach pain
|
7.7%
2/26 • Number of events 8 • Assessed up to 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
7.7%
2/26 • Number of events 3 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Toothache
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Nervous system disorders
Tremor
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
3.8%
1/26 • Number of events 3 • Assessed up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
11.5%
3/26 • Number of events 5 • Assessed up to 2 years
|
|
Renal and urinary disorders
Urine discoloration
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Nervous system disorders
Vasovagal reaction
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
3.8%
1/26 • Number of events 1 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
4/26 • Number of events 4 • Assessed up to 2 years
|
|
Investigations
Weight gain
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
|
Investigations
Weight loss
|
15.4%
4/26 • Number of events 10 • Assessed up to 2 years
|
|
Investigations
White blood cell decreased
|
42.3%
11/26 • Number of events 35 • Assessed up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
30.8%
8/26 • Number of events 13 • Assessed up to 2 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.7%
2/26 • Number of events 2 • Assessed up to 2 years
|
Additional Information
Dr. John Reneau
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-3196
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place