Trial Outcomes & Findings for Administration of T Lymphocytes for Prevention of Relapse of Lymphomas (NCT NCT02663297)
NCT ID: NCT02663297
Last Updated: 2025-05-15
Results Overview
The Maximum tolerated dose was based on the rate of dose-limiting toxicity. Toxicity was classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0), and cytokine release syndrome (CRS). The number of subjects with dose-limiting toxicity was recorded.CTCAE Grade 1 Mild, Grade 2 Moderate, Grade 3, Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Cytokine Release Syndrome (CRS) will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild Grade 2 - Moderate, Grade 3 - Severe (Aggressive Intervention): Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38oC, Hypotension requiring multiple vasopressors, Hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-05-15
Participant Flow
Between June 7, 2016, and Nov 30, 2020, 18 participants were enrolled.
18 patients were found eligible and started the study in 2 centers in the United States.
Participant milestones
| Measure |
Dose Level 1
Each patient will receive one injection of cell dose 2 × 10\^7 CAR T cells per square meter.
|
Dose Level 2
Each patient will receive one injection of cell dose 1 × 10\^8 CAR T cells per square meter.
|
Dose Level 3
Each patient will receive one injection of cell dose 2 × 10\^8 CAR T cells per square meter.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
9
|
|
Overall Study
COMPLETED
|
4
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Administration of T Lymphocytes for Prevention of Relapse of Lymphomas
Baseline characteristics by cohort
| Measure |
Level 1
n=4 Participants
Each patient will receive one injection of cell dose 2 × 10\^7 CAR T cells per square meter.
|
Level 2
n=5 Participants
Each patient will receive one injection of cell dose 1 × 10\^8 CAR T cells per square meter.
|
Level 3
n=9 Participants
Each patient will receive one injection of cell dose 2 × 10\^8 CAR T cells per square meter.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.04 years
n=5 Participants
|
35.12 years
n=7 Participants
|
50.30 years
n=5 Participants
|
41.34 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
18 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe Maximum tolerated dose was based on the rate of dose-limiting toxicity. Toxicity was classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0), and cytokine release syndrome (CRS). The number of subjects with dose-limiting toxicity was recorded.CTCAE Grade 1 Mild, Grade 2 Moderate, Grade 3, Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Cytokine Release Syndrome (CRS) will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild Grade 2 - Moderate, Grade 3 - Severe (Aggressive Intervention): Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38oC, Hypotension requiring multiple vasopressors, Hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.
Outcome measures
| Measure |
Level 1
n=4 Participants
Each patient will receive one injection of cell dose 2 × 10\^7 CAR T cells per square meter.
|
Level 2
n=5 Participants
Each patient will receive one injection of cell dose 1 × 10\^8 CAR T cells per square meter.
|
Level 3
n=9 Participants
Each patient will receive one injection of cell dose 2 × 10\^8 CAR T cells per square meter.
|
|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Escalating Doses of Autologous Activated T Lymphocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 15 yearsPersistence of CAR.CD30 T cells in vivo will be determined by quantitative polymerase chain reaction (PCR) and flow cytometry in peripheral blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 yearsPFS is defined from day of ASCT to relapse (in subjects with a documented complete response after ASCT) or progression (in subjects with documented stable disease or partial response after ASCT), or death as a result of any cause as per the Revised Response Criteria for Malignant Lymphoma
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 yearsOverall survival will be measured from the date of administration of CAR.CD30 transduced ATL to date of death
Outcome measures
Outcome data not reported
Adverse Events
Level 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Level 2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Level 3
Serious events: 0 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Level 1
n=4 participants at risk
Each patient will receive one injection of cell dose 2 × 10\^7 CAR T cells per square meter.
|
Level 2
n=5 participants at risk
Each patient will receive one injection of cell dose 1 × 10\^8 CAR T cells per square meter.
|
Level 3
n=9 participants at risk
Each patient will receive one injection of cell dose 2 × 10\^8 CAR T cells per square meter.
|
|---|---|---|---|
|
General disorders
Fever
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
Other adverse events
| Measure |
Level 1
n=4 participants at risk
Each patient will receive one injection of cell dose 2 × 10\^7 CAR T cells per square meter.
|
Level 2
n=5 participants at risk
Each patient will receive one injection of cell dose 1 × 10\^8 CAR T cells per square meter.
|
Level 3
n=9 participants at risk
Each patient will receive one injection of cell dose 2 × 10\^8 CAR T cells per square meter.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
40.0%
2/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
33.3%
3/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
40.0%
2/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
22.2%
2/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
3/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
40.0%
2/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
22.2%
2/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Eye disorders
Blurred vision
|
25.0%
1/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
22.2%
2/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
40.0%
2/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
33.3%
3/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
60.0%
3/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
44.4%
4/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
General disorders
Fever
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
General disorders
Flu like symptoms
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
22.2%
2/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
1/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
33.3%
3/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
40.0%
2/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Lymphocyte count decreased
|
75.0%
3/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
60.0%
3/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
100.0%
9/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
22.2%
2/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
40.0%
2/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
44.4%
4/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Neutrophil count decreased
|
50.0%
2/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
40.0%
2/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
66.7%
6/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
80.0%
4/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
55.6%
5/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
22.2%
2/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
22.2%
2/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
40.0%
2/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
Weight loss
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Investigations
White blood cell decreased
|
50.0%
2/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
60.0%
3/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
77.8%
7/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Vascular disorders
hypotension
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
40.0%
2/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Psychiatric disorders
confusion
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Gastrointestinal disorders
oral pain
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
20.0%
1/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
0.00%
0/5 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
11.1%
1/9 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 3 years)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
|
Additional Information
Melahat Canter
UNC Lineberger Comprehensive Cancer Center
Phone: 919-962-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Subcontractor agrees that the first publication of the Study results will be made by Institution as a multi-site publication. Subcontractor can publish its site-specific results after Institution's publication, 12 months post-study completion, or upon Institution's notice of completion. Subcontractor must provide Institution 30 days for manuscript review and may delay publication for 45 days for institution's patent filing. Institution will register the Study and post results as required by law.
- Publication restrictions are in place
Restriction type: OTHER