Trial Outcomes & Findings for Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma (NCT NCT00019682)
NCT ID: NCT00019682
Last Updated: 2017-11-20
Results Overview
A complete response (CR) was defined as the disappearance of all clinical evidence of disease for at least 4 weeks. A partial response (PR) was defined as a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions could appear, and none could increase 25% or more.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
185 participants
Primary outcome timeframe
Up to 12 years
Results posted on
2017-11-20
Participant Flow
Participant milestones
| Measure |
Arm I (Aldesleukin)
Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
gp100 Antigen: Given SC
Montanide ISA 51 VG: Given SC
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
91
|
|
Overall Study
COMPLETED
|
93
|
85
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Arm I (Aldesleukin)
n=94 Participants
Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
n=91 Participants
Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
gp100 Antigen: Given SC
Montanide ISA 51 VG: Given SC
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
n=5 Participants
|
46.9 years
n=7 Participants
|
48.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 yearsA complete response (CR) was defined as the disappearance of all clinical evidence of disease for at least 4 weeks. A partial response (PR) was defined as a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions could appear, and none could increase 25% or more.
Outcome measures
| Measure |
Arm I (Aldesleukin)
n=93 Participants
Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
n=85 Participants
Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
gp100 Antigen: Given SC
Montanide ISA 51 VG: Given SC
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Best Response Rate (Partial Response [PR] + Complete Response [CR])
|
6 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization until documentation of progression or last follow up, assessed up to 12 yearsProgression free survival was compared between groups by means of Kaplan-Meier curves using the log-rank test to evaluate the significance of the difference between the arms.
Outcome measures
| Measure |
Arm I (Aldesleukin)
n=94 Participants
Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
n=91 Participants
Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
gp100 Antigen: Given SC
Montanide ISA 51 VG: Given SC
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Progression Free Survival
|
1.6 months
Interval 1.5 to 1.8
|
2.2 months
Interval 1.7 to 3.9
|
SECONDARY outcome
Timeframe: Baseline to up to 12 yearsPopulation: All patients with paired cryopreserved peripheral blood lymphocytes obtained before any treatment and after completing 4 cycles of treatment.
To measure change in T-cell precursors, PBMC were tested for reactivity by measuring gamma-interferon release after overnight coculture with peptide pulsed T2 cells. PBMC obtained after 4 cycles of study treatment were compared to pre treatment PBMC. A positive assay was defined as greater than 100pg/ml gamma-interferon release and at least twice the release (including all control peptides) by post treatment PBMC compared to pre treatment PBMC.
Outcome measures
| Measure |
Arm I (Aldesleukin)
n=12 Participants
Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
n=37 Participants
Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
gp100 Antigen: Given SC
Montanide ISA 51 VG: Given SC
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Change in T-cell Precursors
|
0 Participants with a positive assay
|
7 Participants with a positive assay
|
SECONDARY outcome
Timeframe: Baseline to up to 8 weeksQOL was measured before and after 2 cycles of treatment using 4 measures: FACT-G is a 27 item measure of QOL. A total score is calculated by summing across responses on a 5 point scale and ranges from 0-135, with higher scores indicating better QOL. FACT-F is 13 item measure of fatigue. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 0-52, with higher scores indicating less fatigue. SF-36 is a 36 item measure of self-reported health status. SF-36 is comprised of 8 subscales: physical function, role physical, bodily pain vitality, role emotional function, mental health, social function and general health. Summated scores range from 0-100, with higher scores indicating a better health state. SDS is a 13 item measure of symptom distress. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 13 to 65, with higher scores indicating more symptom distress.
Outcome measures
| Measure |
Arm I (Aldesleukin)
n=93 Participants
Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
n=85 Participants
Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
gp100 Antigen: Given SC
Montanide ISA 51 VG: Given SC
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Pre treatment FACT-G
|
84.2 units on a scale
Standard Error 2.77
|
83.8 units on a scale
Standard Error 2.74
|
|
Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Post treatment FACT-G
|
76.4 units on a scale
Standard Error 2.75
|
81.2 units on a scale
Standard Error 2.71
|
|
Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Pre treatment FACT-F
|
43.1 units on a scale
Standard Error 1.47
|
41.5 units on a scale
Standard Error 1.42
|
|
Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Post treatment FACT-F
|
36.1 units on a scale
Standard Error 1.78
|
36.3 units on a scale
Standard Error 1.73
|
|
Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Pre treatment SF-36
|
49.1 units on a scale
Standard Error 1.93
|
46.6 units on a scale
Standard Error 1.85
|
|
Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Post treatment SF-36
|
42.6 units on a scale
Standard Error 1.94
|
42.9 units on a scale
Standard Error 1.89
|
|
Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Pre treatment SDS
|
21.3 units on a scale
Standard Error 1.05
|
21.2 units on a scale
Standard Error 1.05
|
|
Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Post treatment SDS
|
24.6 units on a scale
Standard Error 1.17
|
22.8 units on a scale
Standard Error 1.17
|
Adverse Events
Arm I (Aldesleukin)
Serious events: 1 serious events
Other events: 93 other events
Deaths: 0 deaths
Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Serious events: 2 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Aldesleukin)
n=93 participants at risk
Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
n=85 participants at risk
Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
gp100 Antigen: Given SC
Montanide ISA 51 VG: Given SC
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
General disorders
Death
|
1.1%
1/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
2.4%
2/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
Other adverse events
| Measure |
Arm I (Aldesleukin)
n=93 participants at risk
Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
n=85 participants at risk
Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Aldesleukin: Given IV
gp100 Antigen: Given SC
Montanide ISA 51 VG: Given SC
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood or bone marrow
|
35.5%
33/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
48.2%
41/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Cardiac disorders
Arrhythmia
|
4.3%
4/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
18.8%
16/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Cardiac disorders
General
|
26.9%
25/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
36.5%
31/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
General disorders
Constitutional symptoms
|
16.1%
15/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
28.2%
24/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Skin and subcutaneous tissue disorders
Skin
|
6.5%
6/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
7.1%
6/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Gastrointestinal disorders
Gastrointestinal
|
18.3%
17/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
21.2%
18/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Hepatobiliary disorders
Hepatic
|
38.7%
36/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
40.0%
34/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Infections and infestations
Infection or febrile neutropenia
|
6.5%
6/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
8.2%
7/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Metabolism and nutrition disorders
Metabolic or laboratory-testing result
|
20.4%
19/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
42.4%
36/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.2%
3/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
7.1%
6/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Nervous system disorders
Neurologic
|
11.8%
11/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
25.9%
22/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
20.4%
19/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
22.4%
19/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
General disorders
Pain
|
10.8%
10/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
12.9%
11/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
|
Renal and urinary disorders
Renal or genitourinary
|
15.1%
14/93
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
18.8%
16/85
NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60