Trial Outcomes & Findings for Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma (NCT NCT02470091)
NCT ID: NCT02470091
Last Updated: 2024-01-22
Results Overview
Disease control interval was calculated as the time from enrolment until detection of new disease or progression of an existing site of disease as determined by the treating physician. Disease control interval of at least 4 months was considered disease control success.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
At 4 months
Results posted on
2024-01-22
Participant Flow
Participant milestones
| Measure |
Cohort 1: Measurable
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
40
|
|
Overall Study
Follow-up Report
|
1
|
10
|
|
Overall Study
COMPLETED
|
15
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1: Measurable
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Ineligible
|
0
|
2
|
Baseline Characteristics
Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma
Baseline characteristics by cohort
| Measure |
Cohort 1: Measurable
n=16 Participants
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
n=40 Participants
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15 years
n=5 Participants
|
17 years
n=7 Participants
|
16 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
42 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
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
39 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 4 monthsPopulation: 1 patient was excluded due to withdrawal.
Disease control interval was calculated as the time from enrolment until detection of new disease or progression of an existing site of disease as determined by the treating physician. Disease control interval of at least 4 months was considered disease control success.
Outcome measures
| Measure |
Cohort 1: Measurable
n=15 Participants
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Disease Control Rate (Cohort I)
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: At 4 monthsPopulation: 1 patient was excluded due to withdrawal.
Per Response Evaluation Criteria In Solid TumorsCriteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Cohort 1: Measurable
n=15 Participants
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Response Evaluation Criteria in Solid Tumors (RECIST) Response (Complete Response [CR] or Partial Response [PR] vs Not CR or PR) (Cohort I)
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: At 12 monthsPopulation: 2 patients were excluded due to ineligibility
Disease control interval was calculated as the time from enrolment until detection of new disease as determined by the treating physician. Disease control interval of at least 12 months was considered disease control success.
Outcome measures
| Measure |
Cohort 1: Measurable
n=38 Participants
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Disease Control Rate (Cohort II)
|
10 participants
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6Population: The number of patients who contributed samples varied across cycles.
Sample means of trough concentrations of denosumab will be calculated.
Outcome measures
| Measure |
Cohort 1: Measurable
n=15 Participants
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
n=27 Participants
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 1, Day 1
|
0 ng/ml
Standard Deviation 0
|
0 ng/ml
Standard Deviation 0
|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 1, Day 8
|
11.59 ng/ml
Standard Deviation 3.836665219
|
10.81 ng/ml
Standard Deviation 4.514421336
|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 1, Day 15
|
20.57 ng/ml
Standard Deviation 8.290958931
|
22.07 ng/ml
Standard Deviation 10.0339424
|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 1, Day 22
|
31.8 ng/ml
Standard Deviation 12.85573802
|
31.56 ng/ml
Standard Deviation 13.41044369
|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 2, Day 1
|
30.57 ng/ml
Standard Deviation 10.78239306
|
30.28 ng/ml
Standard Deviation 11.77497346
|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 3, Day 1
|
23.8 ng/ml
Standard Deviation NA
Only 1 participant was analyzed
|
27.49 ng/ml
Standard Deviation 13.31277582
|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 4, Day 1
|
23.7 ng/ml
Standard Deviation NA
Only 1 participant was analyzed
|
23.67 ng/ml
Standard Deviation 11.83849653
|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 6, Day 1
|
20.3 ng/ml
Standard Deviation NA
Only 1 participant was analyzed
|
31.22 ng/ml
Standard Deviation 14.57292009
|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 6, Day 15
|
23.2 ng/ml
Standard Deviation NA
Only 1 participant was analyzed
|
26.66 ng/ml
Standard Deviation 11.95742447
|
|
Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 7, Day 1
|
—
|
30.22 ng/ml
Standard Deviation 13.89748179
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6Population: The number of patients who contributed samples varied across cycles.
Sample medians of trough concentrations of denosumab will be calculated.
Outcome measures
| Measure |
Cohort 1: Measurable
n=15 Participants
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
n=27 Participants
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 1, Day 1
|
0 ng/ml
Interval 0.0 to 0.0
|
0 ng/ml
Interval 0.0 to 0.0
|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 1, Day 8
|
10.8 ng/ml
Interval 5.54 to 19.8
|
9.34 ng/ml
Interval 6.23 to 25.1
|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 1, Day 15
|
20.7 ng/ml
Interval 5.96 to 35.7
|
18.75 ng/ml
Interval 12.9 to 54.5
|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 1, Day 22
|
27.85 ng/ml
Interval 15.2 to 57.6
|
27.6 ng/ml
Interval 17.1 to 74.0
|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 2, Day 1
|
30.75 ng/ml
Interval 13.6 to 49.9
|
27.3 ng/ml
Interval 17.0 to 63.3
|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 3, Day 1
|
23.8 ng/ml
Interval 23.8 to 23.8
|
22.8 ng/ml
Interval 13.8 to 61.0
|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 4, Day 1
|
23.7 ng/ml
Interval 23.7 to 23.7
|
21.6 ng/ml
Interval 10.6 to 48.8
|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 6, Day 1
|
20.3 ng/ml
Interval 20.3 to 20.3
|
32.05 ng/ml
Interval 14.9 to 51.5
|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 6, Day 15
|
23.2 ng/ml
Interval 23.2 to 23.2
|
23.5 ng/ml
Interval 12.1 to 49.1
|
|
Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab
Serum denosumab (ng/ml): Cycle 7, Day 1
|
—
|
27.95 ng/ml
Interval 17.9 to 56.5
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7Population: All eligible participants
Serum c-telopeptide in pg/ml
Outcome measures
| Measure |
Cohort 1: Measurable
n=15 Participants
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
n=38 Participants
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Serum c-telopeptide (pg/ml): Cycle 1, Day 1
|
1713 pg/ml
Standard Deviation 1857
|
944.5 pg/ml
Standard Deviation 543
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Serum c-telopeptide (pg/ml): Cycle 1, Day 8
|
220.5 pg/ml
Standard Deviation 77
|
244.0625 pg/ml
Standard Deviation 259
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Serum c-telopeptide (pg/ml): Cycle 1, Day 15
|
203.1818 pg/ml
Standard Deviation 68
|
171.24 pg/ml
Standard Deviation 86
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Serum c-telopeptide (pg/ml): Cycle 1, Day 22
|
210.8889 pg/ml
Standard Deviation 95
|
178.5033 pg/ml
Standard Deviation 96
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Serum c-telopeptide (pg/ml): Cycle 2, Day 1
|
200.8 pg/ml
Standard Deviation 78
|
152.2032 pg/ml
Standard Deviation 61
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Serum c-telopeptide (pg/ml): Cycle 3, Day 1
|
115 pg/ml
|
147.8818 pg/ml
Standard Deviation 85
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Serum c-telopeptide (pg/ml): Cycle 4, Day 1
|
116 pg/ml
|
137.0235 pg/ml
Standard Deviation 80
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide
Serum c-telopeptide (pg/ml): Cycle 7, Day 1
|
108 pg/ml
|
168.9 pg/ml
Standard Deviation 81
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7Population: All eligible participants
Urine n-telopeptide to creatinine ratio expressed as nMol BCE/mmol creatinine
Outcome measures
| Measure |
Cohort 1: Measurable
n=15 Participants
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
n=38 Participants
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Urine n-telopeptide to creatinine ratio (nMol BCE/mmol creatinine): Cycle 1, Day 1
|
322.2 nMol BCE/mmol creatinine
Standard Deviation 307
|
190.7714 nMol BCE/mmol creatinine
Standard Deviation 283
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Urine n-telopeptide to creatinine ratio (nMol BCE/mmol creatinine): Cycle 1, Day 8
|
30.36364 nMol BCE/mmol creatinine
Standard Deviation 20
|
34.1875 nMol BCE/mmol creatinine
Standard Deviation 35
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Urine n-telopeptide to creatinine ratio (nMol BCE/mmol creatinine): Cycle 1, Day 15
|
26.18182 nMol BCE/mmol creatinine
Standard Deviation 14
|
32.3 nMol BCE/mmol creatinine
Standard Deviation 36
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Urine n-telopeptide to creatinine ratio (nMol BCE/mmol creatinine): Cycle 1, Day 22
|
26.55556 nMol BCE/mmol creatinine
Standard Deviation 19
|
32.16129 nMol BCE/mmol creatinine
Standard Deviation 40
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Urine n-telopeptide to creatinine ratio (nMol BCE/mmol creatinine): Cycle 2, Day 1
|
22.1 nMol BCE/mmol creatinine
Standard Deviation 15
|
28.42857 nMol BCE/mmol creatinine
Standard Deviation 45
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Urine n-telopeptide to creatinine ratio (nMol BCE/mmol creatinine): Cycle 3, Day 1
|
14 nMol BCE/mmol creatinine
|
24.7619 nMol BCE/mmol creatinine
Standard Deviation 20
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Urine n-telopeptide to creatinine ratio (nMol BCE/mmol creatinine): Cycle 4, Day 1
|
20 nMol BCE/mmol creatinine
|
29.29412 nMol BCE/mmol creatinine
Standard Deviation 31
|
|
Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio
Urine n-telopeptide to creatinine ratio (nMol BCE/mmol creatinine): Cycle 7, Day 1
|
13 nMol BCE/mmol creatinine
|
22.4 nMol BCE/mmol creatinine
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Minimum of 2 yearsPopulation: 56 patients were treated on protocol therapy. Three hundred seventy-three cycles were reported for the analysis of dose limiting toxicity
The number of cycles where a dose-limiting toxicity was identified where dose-limiting toxicity is defined in the protocol using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Cohort 1: Measurable
n=373 cycles
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
|
1 cycles
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years post-treatmentPopulation: There were not any patients that met criteria for bone site
Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 4 monthsPopulation: There were not any patients that met criteria for bone site
Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Patients that met criteria for bone site
Disease control interval was calculated at the time from enrolment until detection of new disease as determined by the treating physician. The proportion of patients who experience disease control of at least 12 months will be estimated by the method of Kaplan and Meier.
Outcome measures
| Measure |
Cohort 1: Measurable
n=6 Participants
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort II)
|
0.667 proportion of patients
Interval 0.195 to 0.904
|
—
|
Adverse Events
Cohort 1: Measurable
Serious events: 6 serious events
Other events: 1 other events
Deaths: 13 deaths
Cohort 2: Resection
Serious events: 4 serious events
Other events: 8 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Cohort 1: Measurable
n=15 participants at risk
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
n=38 participants at risk
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
2.6%
1/38 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
General disorders
Fever
|
13.3%
2/15 • Number of events 2 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Investigations
Weight loss
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
3/15 • Number of events 3 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
7.9%
3/38 • Number of events 3 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
3/15 • Number of events 3 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.3%
2/15 • Number of events 2 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
2.6%
1/38 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Vascular disorders
Hematoma
|
0.00%
0/15 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
2.6%
1/38 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
Other adverse events
| Measure |
Cohort 1: Measurable
n=15 participants at risk
Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
Cohort 2: Resection
n=38 participants at risk
Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
|
|---|---|---|
|
Investigations
Lymphocyte count decreased
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Investigations
Weight gain
|
0.00%
0/15 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
2.6%
1/38 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/15 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
2.6%
1/38 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
0.00%
0/38 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/15 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
2.6%
1/38 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/15 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
2.6%
1/38 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
15.8%
6/38 • Number of events 6 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/15 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
2.6%
1/38 • Number of events 1 • Through completion protocol therapy planned as 728 days after study enrollment
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior sponsor approval
- Publication restrictions are in place
Restriction type: OTHER