Trial Outcomes & Findings for Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma (NCT NCT03113500)
NCT ID: NCT03113500
Last Updated: 2025-11-14
Results Overview
CR rate was estimated by the proportion of evaluable patients achieving CR after CHEP-BV induction therapy, along with the 95% exact binomial confidence interval.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Up to the end of the CHEP-BV treatment
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
Treatment (CHEP-BV)
INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Cyclophosphamide: Given IV
Doxorubicin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Prednisone: Given PO
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (CHEP-BV)
INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Cyclophosphamide: Given IV
Doxorubicin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Prednisone: Given PO
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (CHEP-BV)
n=48 Participants
INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Cyclophosphamide: Given IV
Doxorubicin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Prednisone: Given PO
|
|---|---|
|
Age, Continuous
|
56 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to the end of the CHEP-BV treatmentPopulation: 1 subject had no disease assessment.
CR rate was estimated by the proportion of evaluable patients achieving CR after CHEP-BV induction therapy, along with the 95% exact binomial confidence interval.
Outcome measures
| Measure |
Treatment (CHEP-BV)
n=47 Participants
INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Cyclophosphamide: Given IV
Doxorubicin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Prednisone: Given PO
|
|---|---|
|
Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy
|
79 percentage of response rate
Interval 64.0 to 89.0
|
SECONDARY outcome
Timeframe: The time from enrollment to death from any cause assessed up to 1 year.Overall survival (OS) was measured from enrollment to death from any cause. OS was estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error.
Outcome measures
| Measure |
Treatment (CHEP-BV)
n=48 Participants
INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Cyclophosphamide: Given IV
Doxorubicin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Prednisone: Given PO
|
|---|---|
|
Overall Survival at 1 Year
|
91 percentage of survival probability
Interval 78.0 to 97.0
|
Adverse Events
Treatment (CHEP-BV)
Serious events: 22 serious events
Other events: 48 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (CHEP-BV)
n=48 participants at risk
INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Cyclophosphamide: Given IV
Doxorubicin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Prednisone: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
3/48 • Number of events 3 • Up to 30 days post treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
22.9%
11/48 • Number of events 13 • Up to 30 days post treatment
|
|
Blood and lymphatic system disorders
eosinophilia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Colitis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
perforated sigmoid diverticulitis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
Chills
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
Fatigue
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
Fever
|
12.5%
6/48 • Number of events 9 • Up to 30 days post treatment
|
|
Infections and infestations
Infection, NOS
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
Skin infection
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Infections and infestations
Upper respiratory infection
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
c. septicum infection
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
c.diff infection
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
Platelet count decreased
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Vascular disorders
Thromboembolic event
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
Other adverse events
| Measure |
Treatment (CHEP-BV)
n=48 participants at risk
INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin: Given IV
Cyclophosphamide: Given IV
Doxorubicin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Prednisone: Given PO
|
|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
35.4%
17/48 • Number of events 29 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
70.8%
34/48 • Number of events 87 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Odynophagia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
3/48 • Number of events 3 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Proctitis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Rectal pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Stomach pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
35.4%
17/48 • Number of events 25 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
blood in stool
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
tarry stools
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
Chills
|
12.5%
6/48 • Number of events 10 • Up to 30 days post treatment
|
|
General disorders
Edema limbs
|
8.3%
4/48 • Number of events 4 • Up to 30 days post treatment
|
|
General disorders
Fatigue
|
81.2%
39/48 • Number of events 105 • Up to 30 days post treatment
|
|
General disorders
Fever
|
29.2%
14/48 • Number of events 18 • Up to 30 days post treatment
|
|
General disorders
Flu like symptoms
|
6.2%
3/48 • Number of events 3 • Up to 30 days post treatment
|
|
General disorders
Gait disturbance
|
12.5%
6/48 • Number of events 7 • Up to 30 days post treatment
|
|
General disorders
Infusion related reaction
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
Injection site reaction
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
Localized edema
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
General disorders
Malaise
|
16.7%
8/48 • Number of events 11 • Up to 30 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
8.3%
4/48 • Number of events 4 • Up to 30 days post treatment
|
|
General disorders
Pain
|
18.8%
9/48 • Number of events 15 • Up to 30 days post treatment
|
|
General disorders
back paresthesia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
coated tounge
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
cold sore
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
muscle pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
spleen paresthesia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
General disorders
tongue sensitivity
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Immune system disorders
lymphomatoid papulosis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
CELLULITIS
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
DIFF INFECTION
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
DIFFICILE
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
Device related infection
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
Lung infection
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Infections and infestations
Mucosal infection
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
Other; Bacteremia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
Papulopustular rash
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
Skin infection
|
8.3%
4/48 • Number of events 7 • Up to 30 days post treatment
|
|
Infections and infestations
Strep bacteremia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
Upper respiratory infection
|
14.6%
7/48 • Number of events 9 • Up to 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
6.2%
3/48 • Number of events 6 • Up to 30 days post treatment
|
|
Infections and infestations
gram positive cocci infection
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Infections and infestations
oral thrush
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Infections and infestations
shingles
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
4/48 • Number of events 6 • Up to 30 days post treatment
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.2%
2/48 • Number of events 15 • Up to 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
37.5%
18/48 • Number of events 58 • Up to 30 days post treatment
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
8/48 • Number of events 10 • Up to 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
35.4%
17/48 • Number of events 36 • Up to 30 days post treatment
|
|
Investigations
Blood bilirubin increased
|
18.8%
9/48 • Number of events 9 • Up to 30 days post treatment
|
|
Investigations
CD4 lymphocytes decreased
|
8.3%
4/48 • Number of events 7 • Up to 30 days post treatment
|
|
Investigations
CPK increased
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
Cardiac troponin I increased
|
4.2%
2/48 • Number of events 3 • Up to 30 days post treatment
|
|
Investigations
Creatinine increased
|
12.5%
6/48 • Number of events 22 • Up to 30 days post treatment
|
|
Investigations
Ejection fraction decreased
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
Elevated Lactic Acid
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
GGT increased
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
INR increased
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
Increased white blood cells
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
Lipase increased
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
Lymphocyte count decreased
|
47.9%
23/48 • Number of events 80 • Up to 30 days post treatment
|
|
Investigations
Lymphocyte count increased
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Investigations
Neutrophil count decreased
|
56.2%
27/48 • Number of events 72 • Up to 30 days post treatment
|
|
Investigations
Platelet count decreased
|
50.0%
24/48 • Number of events 79 • Up to 30 days post treatment
|
|
Investigations
Serum amylase increased
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Investigations
Weight gain
|
14.6%
7/48 • Number of events 25 • Up to 30 days post treatment
|
|
Investigations
Weight loss
|
14.6%
7/48 • Number of events 13 • Up to 30 days post treatment
|
|
Investigations
White blood cell decreased
|
43.8%
21/48 • Number of events 59 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
12/48 • Number of events 22 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
10.4%
5/48 • Number of events 7 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
8/48 • Number of events 18 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
6/48 • Number of events 18 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
8/48 • Number of events 17 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.6%
7/48 • Number of events 12 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
6/48 • Number of events 12 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
16/48 • Number of events 24 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.8%
9/48 • Number of events 19 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.2%
15/48 • Number of events 30 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
22.9%
11/48 • Number of events 18 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Iron overload
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Obesity
|
6.2%
3/48 • Number of events 9 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.2%
3/48 • Number of events 3 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
8/48 • Number of events 12 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.9%
11/48 • Number of events 16 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
8/48 • Number of events 11 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Foot drop
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
4/48 • Number of events 5 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Interscapular pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.8%
10/48 • Number of events 22 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.8%
9/48 • Number of events 29 • Up to 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Nervous system disorders
Cognitive disturbance
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Nervous system disorders
Dizziness
|
37.5%
18/48 • Number of events 29 • Up to 30 days post treatment
|
|
Nervous system disorders
Dysgeusia
|
14.6%
7/48 • Number of events 9 • Up to 30 days post treatment
|
|
Nervous system disorders
Headache
|
27.1%
13/48 • Number of events 21 • Up to 30 days post treatment
|
|
Nervous system disorders
Memory impairment
|
6.2%
3/48 • Number of events 3 • Up to 30 days post treatment
|
|
Nervous system disorders
Neuralgia
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Nervous system disorders
Parathesia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Nervous system disorders
Paresthesia
|
2.1%
1/48 • Number of events 3 • Up to 30 days post treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.4%
5/48 • Number of events 8 • Up to 30 days post treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
68.8%
33/48 • Number of events 135 • Up to 30 days post treatment
|
|
Nervous system disorders
Presyncope
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Nervous system disorders
Tingling sensation in fingers/feet
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Psychiatric disorders
Agitation
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Psychiatric disorders
Anxiety
|
16.7%
8/48 • Number of events 11 • Up to 30 days post treatment
|
|
Psychiatric disorders
Confusion
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Psychiatric disorders
Depression
|
12.5%
6/48 • Number of events 7 • Up to 30 days post treatment
|
|
Psychiatric disorders
Hallucinations
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Psychiatric disorders
Insomnia
|
25.0%
12/48 • Number of events 33 • Up to 30 days post treatment
|
|
Psychiatric disorders
Personality change
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Psychiatric disorders
Restlessness
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Psychiatric disorders
Sleep disturbance
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Psychiatric disorders
intermittent mood changes
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Renal and urinary disorders
Difficulty with urination
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Renal and urinary disorders
Hematuria
|
6.2%
3/48 • Number of events 4 • Up to 30 days post treatment
|
|
Renal and urinary disorders
Proteinuria
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
4/48 • Number of events 4 • Up to 30 days post treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Renal and urinary disorders
Urinary tract pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Renal and urinary disorders
dysuria
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Reproductive system and breast disorders
Breast pain
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
4/48 • Number of events 4 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
12/48 • Number of events 20 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.8%
10/48 • Number of events 26 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
4/48 • Number of events 4 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
2/48 • Number of events 4 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
3/48 • Number of events 3 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
2.1%
1/48 • Number of events 3 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
18.8%
9/48 • Number of events 19 • Up to 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
3/48 • Number of events 6 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.8%
9/48 • Number of events 10 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Changes
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
5/48 • Number of events 5 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Facial Abcess
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
3/48 • Number of events 4 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
4.2%
2/48 • Number of events 3 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
9/48 • Number of events 18 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.8%
10/48 • Number of events 17 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin Flare Reaction
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin tear on knuckle
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
blood at the surface of skin
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
brittle nails
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
night sweats
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
papular rash on back and arms
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
skin injury
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
skin lesion on left lateral thigh
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Vascular disorders
Flushing
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Vascular disorders
Hot flashes
|
8.3%
4/48 • Number of events 5 • Up to 30 days post treatment
|
|
Vascular disorders
Hypertension
|
29.2%
14/48 • Number of events 76 • Up to 30 days post treatment
|
|
Vascular disorders
Hypotension
|
20.8%
10/48 • Number of events 16 • Up to 30 days post treatment
|
|
Vascular disorders
Thromboembolic event
|
6.2%
3/48 • Number of events 9 • Up to 30 days post treatment
|
|
Vascular disorders
vascular access complication
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Blood and lymphatic system disorders
Anemia
|
68.8%
33/48 • Number of events 148 • Up to 30 days post treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.8%
10/48 • Number of events 11 • Up to 30 days post treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Cardiac disorders
Chest pain - cardiac
|
2.1%
1/48 • Number of events 3 • Up to 30 days post treatment
|
|
Cardiac disorders
Palpitations
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Cardiac disorders
Sinus bradycardia
|
10.4%
5/48 • Number of events 8 • Up to 30 days post treatment
|
|
Cardiac disorders
Sinus tachycardia
|
27.1%
13/48 • Number of events 30 • Up to 30 days post treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Ear and labyrinth disorders
Ear pain
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Ear and labyrinth disorders
ear wax
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Eye disorders
Blurred vision
|
12.5%
6/48 • Number of events 8 • Up to 30 days post treatment
|
|
Eye disorders
Conjunctivitis
|
6.2%
3/48 • Number of events 3 • Up to 30 days post treatment
|
|
Eye disorders
Dry eye
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Eye disorders
Eye pain
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Eye disorders
Floaters
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Eye disorders
Itching Around Eyes
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Eye disorders
Keratitis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Eye disorders
Papilledema
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Eye disorders
Retinal tear
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Eye disorders
Watering eyes
|
6.2%
3/48 • Number of events 3 • Up to 30 days post treatment
|
|
Eye disorders
blepharitis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Eye disorders
eye fatigue
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Eye disorders
puffy eyes
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
31.2%
15/48 • Number of events 22 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Anal ulcer
|
2.1%
1/48 • Number of events 2 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Ascites
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Blood In Stools
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Colitis
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Constipation
|
35.4%
17/48 • Number of events 40 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhea
|
39.6%
19/48 • Number of events 32 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
2/48 • Number of events 3 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
14.6%
7/48 • Number of events 7 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Enterocolitis
|
2.1%
1/48 • Number of events 1 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Esophageal pain
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Esophagitis
|
4.2%
2/48 • Number of events 2 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
3/48 • Number of events 4 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.4%
5/48 • Number of events 5 • Up to 30 days post treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.3%
4/48 • Number of events 5 • Up to 30 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place