Trial Outcomes & Findings for Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas (NCT NCT00043979)
NCT ID: NCT00043979
Last Updated: 2017-05-31
Results Overview
Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, \>95% donor engraftment at day 100 in \>75% of patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
100 days
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
Sibling Donors
Donors (n = 30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.In period 1 they donated cells.
|
Recipients Cyclosporine GVHD Prophylaxis
In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.
Post transplant recipients received cyclosporine for GVHD prophylaxis.
|
Recipients Tacrolimus /Sirolimus Prophylaxis
In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.
Post transplant recipients received tacrolimus \& sirolimus for GVHD prophylaxis.
|
|---|---|---|---|
|
Period 1
STARTED
|
30
|
17
|
13
|
|
Period 1
COMPLETED
|
23
|
13
|
10
|
|
Period 1
NOT COMPLETED
|
7
|
4
|
3
|
|
Period 2
STARTED
|
0
|
13
|
10
|
|
Period 2
COMPLETED
|
0
|
13
|
10
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sibling Donors
Donors (n = 30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.In period 1 they donated cells.
|
Recipients Cyclosporine GVHD Prophylaxis
In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.
Post transplant recipients received cyclosporine for GVHD prophylaxis.
|
Recipients Tacrolimus /Sirolimus Prophylaxis
In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.
Post transplant recipients received tacrolimus \& sirolimus for GVHD prophylaxis.
|
|---|---|---|---|
|
Period 1
recipient with progressive disease
|
7
|
4
|
3
|
Baseline Characteristics
This baseline measure only applies to recipients.
Baseline characteristics by cohort
| Measure |
Arm 1-Sibling Donors
n=30 Participants
Donors (n=30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.
|
Arm 2-Recipients
n=30 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
31 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
29 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
21.12 years
STANDARD_DEVIATION 10.9 • n=30 Participants
|
19.98 years
STANDARD_DEVIATION 5.8 • n=30 Participants
|
20.55 years
STANDARD_DEVIATION 8.35 • n=60 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
29 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=30 Participants
|
20 Participants
n=30 Participants
|
31 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=30 Participants
|
29 Participants
n=30 Participants
|
58 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 1
|
—
|
5 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
5 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 2
|
—
|
3 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
3 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 3
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 4
|
—
|
3 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
3 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 6
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 8
|
—
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 9
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 10
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 12
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 13
|
—
|
3 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
3 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 14
|
—
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 15
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 17
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 18
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 20
|
—
|
3 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
3 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 21
|
—
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 22
|
—
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 24
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 25
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 27
|
—
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 28 (c)
|
—
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 29
|
—
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
2 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Received Stem Cell Transplant
Patient # 30
|
—
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
1 regimens
n=23 Participants • This baseline measure only applies to recipients.
|
|
Number of Prior Regimens of Participants that Did Not Receive Stem Cell Transplant
Patient # 5
|
—
|
2 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
2 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
|
Number of Prior Regimens of Participants that Did Not Receive Stem Cell Transplant
Patient # 7
|
—
|
1 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
1 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
|
Number of Prior Regimens of Participants that Did Not Receive Stem Cell Transplant
Patient # 11
|
—
|
3 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
3 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
|
Number of Prior Regimens of Participants that Did Not Receive Stem Cell Transplant
Patient # 16
|
—
|
2 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
2 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
|
Number of Prior Regimens of Participants that Did Not Receive Stem Cell Transplant
Patient # 19
|
—
|
2 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
2 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
|
Number of Prior Regimens of Participants that Did Not Receive Stem Cell Transplant
Patient # 23
|
—
|
4 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
4 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
|
Number of Prior Regimens of Participants that Did Not Receive Stem Cell Transplant
Patient # 26
|
—
|
3 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
3 regimens
n=7 Participants • This baseline measure applies to recipients only.
|
|
Participants who Received Stem Cell Transplant Disease Status at Enrollment
Progressive Disease (PD)
|
—
|
18 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
18 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Participants who Received Stem Cell Transplant Disease Status at Enrollment
No Evidence of Disease (NED)
|
—
|
4 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
4 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Participants who Received Stem Cell Transplant Disease Status at Enrollment
Stable Disease (SD)
|
—
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Participants who Did Not Receive Stem Cell Transplant Disease Status(Progressive Disease)/Enrollment
|
—
|
7 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
7 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
|
Disease Status at Hematopoietic Stem Cell Transplant
Partial Response (PR)
|
—
|
4 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
4 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Disease Status at Hematopoietic Stem Cell Transplant
Stable Disease (SD)
|
—
|
9 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
9 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Disease Status at Hematopoietic Stem Cell Transplant
No Evidence of Disease (NED)
|
—
|
4 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
4 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Disease Status at Hematopoietic Stem Cell Transplant
Progressive Disease (PD)
|
—
|
3 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
3 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Disease Status at Hematopoietic Stem Cell Transplant
Complete Response (CR)/(NED)
|
—
|
3 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
3 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Disease Status (Progressive Disease) at Hematopoietic Stem Cell Transplant
|
—
|
7 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
7 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
|
Diagnosis (Participants that Received Stem Cell Transplant)
aRMS
|
—
|
7 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
7 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Diagnosis (Participants that Received Stem Cell Transplant)
ESFT
|
—
|
5 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
5 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Diagnosis (Participants that Received Stem Cell Transplant)
DSRCT
|
—
|
11 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
11 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
Diagnosis (Participants that Did Not Receive Stem Cell Transplant)
ESFT
|
—
|
6 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
6 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
|
Diagnosis (Participants that Did Not Receive Stem Cell Transplant)
DSRCT
|
—
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Received Stem Cell Transplant)
MR
|
—
|
6 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
6 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Received Stem Cell Transplant)
ER
|
—
|
2 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
2 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Received Stem Cell Transplant)
ER, B/BM, MR
|
—
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Received Stem Cell Transplant)
PP
|
—
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Received Stem Cell Transplant)
B/BM
|
—
|
7 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
7 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Received Stem Cell Transplant)
Metastatic
|
—
|
4 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
4 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Received Stem Cell Transplant)
PP/Metastatic
|
—
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Received Stem Cell Transplant)
PP, B/BM
|
—
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
1 Participants
n=23 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Did Not Receive Stem Cell Transplant)
ER, B/BM
|
—
|
1 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
1 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Did Not Receive Stem Cell Transplant)
PP, B/BM
|
—
|
1 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
1 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Did Not Receive Stem Cell Transplant)
ER
|
—
|
3 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
3 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
|
High-Risk Features (Participants that Did Not Receive Stem Cell Transplant)
PP
|
—
|
2 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
2 Participants
n=7 Participants • This baseline measure applies to recipients only.
|
PRIMARY outcome
Timeframe: 100 daysPopulation: E.g ...in \>75% of patients, shown above is not a conclusion but refers to a hypothesis, the objective of the protocol. 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.
Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, \>95% donor engraftment at day 100 in \>75% of patients.
Outcome measures
| Measure |
Arm 2-Recipients
n=23 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Number of Participants With Engraftment
|
23 Participants
|
—
|
PRIMARY outcome
Timeframe: 16.5 monthsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Arm 2-Recipients
n=30 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Toxicity
|
30 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 5 years or deathAcute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100.
Outcome measures
| Measure |
Arm 2-Recipients
n=13 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
n=10 Participants
|
|---|---|---|
|
Number of Participants With Acute and Chronic GVHD
acute GVHD
|
12 participants
|
5 participants
|
|
Number of Participants With Acute and Chronic GVHD
chronic GVHD
|
12 participants
|
5 participants
|
SECONDARY outcome
Timeframe: up to 12 daysDays for participants to achieve a neutrophil count of 500/mm(3).
Outcome measures
| Measure |
Arm 2-Recipients
n=30 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Median Time to Reach Absolute Neutrophil Count of 500/mm(3)
|
9 Days
Interval 8.0 to 12.0
|
—
|
SECONDARY outcome
Timeframe: up to 43 daysDays for participants to achieve a platelet count of 50,000/mm(3).
Outcome measures
| Measure |
Arm 2-Recipients
n=30 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Median Time to Reach a Platelet Count of 50,000/mm(3)
|
15 Days
Interval 10.0 to 43.0
|
—
|
SECONDARY outcome
Timeframe: up to 300 daysPopulation: One out of 23 participants did not have a recurrence, thus was excluded from analysis.
Participants who experienced recurrence or progression of disease following transplant.
Outcome measures
| Measure |
Arm 2-Recipients
n=22 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Early Post Transplantation Relapse
|
100 Days
Interval 28.0 to 300.0
|
—
|
SECONDARY outcome
Timeframe: up to 77 monthsPopulation: 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.
Progression free survival was based on the time from on-study date until progression or last follow-up.
Outcome measures
| Measure |
Arm 2-Recipients
n=23 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Median Progression Free Survival
|
15.9 Months
Interval 2.2 to 77.0
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.
Participants who are alive at two years following Allo-Hematopoietic Stem Cell Transplant.
Outcome measures
| Measure |
Arm 2-Recipients
n=23 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant
From date of enrollment
|
39.1 percentage of participants
|
—
|
|
Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant
From date of transplantation
|
34.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 daysPopulation: 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.
Participants who tolerated the transplantation regimen and accepted \>95% of the donors blood, marrow, and/or tissue.
Outcome measures
| Measure |
Arm 2-Recipients
n=23 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Number of Participants to Complete Conversion to >95% Donor Chimerism
Day +14
|
23 Participants
|
—
|
|
Number of Participants to Complete Conversion to >95% Donor Chimerism
Day +28
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: Day +28-42The median CD4 count with a range of 85-1565 (absolute count) was used to determine recovery and were considered recovered if in this range. The CD4 count was established by flow cytometry testing.
Outcome measures
| Measure |
Arm 2-Recipients
n=30 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Cluster of Differentiation 4 (CD4) Reconstitution
|
284 mm(3)
Interval 85.0 to 1042.0
|
—
|
SECONDARY outcome
Timeframe: up to 10 cycles of therapy or 280 daysPopulation: EPOCH-F (Etoposide, Vincristine, Prednisone, Cyclophosphamide, Doxorubicin, and Fludarabine) was modified to EOCH and administered to 12 patients for post-transplantation disease progression.
Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). RECIST criteria offer a simplified, conservative, extraction of imaging data for wide application in clinical trials. They presume that linear measures are an adequate substitute for 2-D (dimensional) methods and registers four response categories: Complete response (CR) is disappearance of all target lesions. Partial response (PR) is 30% increase in the sum of the longest diameter of target lesions. Progressive disease (PD) is 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is small changes that do not meet above criteria. For the purposes of this study very good partial response ((VGPR) is \>75% reduction in disease) was also employed.
Outcome measures
| Measure |
Arm 2-Recipients
n=12 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)
Complete Response (CR)
|
2 Participants
|
—
|
|
Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)
Progressive Disease (PD)
|
4 Participants
|
—
|
|
Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)
Partial Response (PR)
|
4 Participants
|
—
|
|
Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)
Very Good Partial Response (VGPR)
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 77 monthsPopulation: 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.
Median survival from date of progression is based on the time from on-study date until progression or last follow-up.
Outcome measures
| Measure |
Arm 2-Recipients
n=23 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Median Survival From Date of Progression
Participants who did not receive a transplant(n=7)
|
3.3 Months
Interval 2.2 to 11.2
|
—
|
|
Median Survival From Date of Progression
Participants who received a transplant (n=23)
|
19.1 Months
Interval 5.6 to 77.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to day 100Population: 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.
GVT is defined as tumor response after day 42 post-transplantation without cytotoxic therapy.
Outcome measures
| Measure |
Arm 2-Recipients
n=23 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 cycles or 168 daysPopulation: G1, grade 1; G2, grade 2; G3, grade 3; G4, grade 4; G5, grade 5. 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.
Site of radiotherapy (high energy radiation) and/or toxicity experienced by the participants post HSCT radiotherapy. Grading was preformed using the Modified Glucksberg Criteria.
Outcome measures
| Measure |
Arm 2-Recipients
n=23 Participants
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis
|
|---|---|---|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Spine, skull; G2 nausea+vomiting, G2 fatigue
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Pelvis; G4 enteritis
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Chest wall; G2 skin
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Abdomen; G4 GI
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Pancreas; G4 LFTs, G4 pancreatitis
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Pleura, mediastinum; G4 LFTs, G2 mucositis
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Chest wall; G4 skin, G3 mucositis
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Pulmonary (cyberknife)
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Brain; B3 mucositis
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Whole lung; G3 mucositis, G3 skin, G5 lung
|
1 Participants
|
—
|
|
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
L arm, R shoulder, B/L femur
|
1 Participants
|
—
|
Adverse Events
Arm 2-Recipients
Serious events: 29 serious events
Other events: 30 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Arm 2-Recipients
n=30 participants at risk
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
|---|---|
|
Cardiac disorders
Cardiac General: Hypotension
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Constitutional Symptoms: Fever
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Renal and urinary disorders
Creatinine
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Death: Death not associated with CTCAE term: Disease progression NOS
|
96.7%
29/30 • Number of events 29 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Diarrhea
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Mucositis/stomatitis (clinical exam)::oral cavity
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
GI, other
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection with neutropenia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection without neutropenia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection: Febrile neutropenia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Intussception
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Bilirubin, serum-high (hyperbilirubinemia)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: ALT, SGPT (serum glutamic pyruvic transaminase)
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: AST, SGOT (serum glutamic oxaloacetic transaminase)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Mood alteration; suicide gesture
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Neurology: Mood alteration: anxiety
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Neurology: Seizure
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
General disorders
Pain - right chest wall
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Pericardial effusion
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Pneumonitis/pulmonary infiltrates
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other (pulmonary edema w/normal 02 sat)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Dyspnea (shortness of breath)
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Hypoxia
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Radiation Recall Reaction (anterior chest)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Stomatitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Thrombosis
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Renal and urinary disorders
Vaginitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Metabolism and nutrition disorders
AST, high
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitits/Pulmonary infiltrates
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
Other adverse events
| Measure |
Arm 2-Recipients
n=30 participants at risk
Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Epidermal abrasions
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Epistaxis
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Erythema, palms of hands
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Erythema - abdominal incision
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Erythema - buccal mucosa
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Erythema-face
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Erythema - right great toe pus
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Erythemateous patchy rash - mild, primarily involving trunk but listed (back, chest, arms)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Esophagitis, chronic
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Eye disorders
Eye discharge
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Eye disorders
Eyes - dry bilateral
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Fibrosis lung
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Fissure
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Flat effect
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Anorexia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Constipation
|
43.3%
13/30 • Number of events 24 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Dental: periodontal disease
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Diarrhea
|
73.3%
22/30 • Number of events 74 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Distention, bloating, abdominal
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Flatulence
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Heartburn/Dyspepsia
|
16.7%
5/30 • Number of events 10 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Hemorrhoids
|
6.7%
2/30 • Number of events 7 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Mucositis/stomatitis (clinical exam)::oral cavity
|
30.0%
9/30 • Number of events 14 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Mucositis/stomatitis (functional/symptomatic)::pharynx
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:Nausea
|
70.0%
21/30 • Number of events 44 • 16.5 months
|
|
Gastrointestinal disorders
GVHD
|
13.3%
4/30 • Number of events 12 • 16.5 months
|
|
Gastrointestinal disorders
GVHD, GI
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
GVHD - cutaneous
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
GVHD, GI & skin & liver
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
GVHD, liver
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
GVHD: skin, liver, oral and vaginal mucosa
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
GVHD - skin, liver, oral buccal mucosa
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Hallucination(s)
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
General disorders
Headache
|
16.7%
5/30 • Number of events 6 • 16.5 months
|
|
General disorders
Headaches-intermittent
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Hematochezia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Hematoma
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Renal and urinary disorders
Hematuria
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, epistaxis
|
13.3%
4/30 • Number of events 4 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage/Bleeding: Hemorrhage, pulmonary/upper respiratory-select
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Hemorrhage/Bleeding: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Reproductive system and breast disorders
Hemorrhage/Bleeding: Vagina
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Hepatobiliary disorders
Hepatic: Bilirubin associated with graft versus host disease (GVHD) for BMT studies,
|
13.3%
4/30 • Number of events 8 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Hives
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia-Hypoxemic
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased cavitary nodular infiltrate in left lower lobe
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection-Other
|
10.0%
3/30 • Number of events 5 • 16.5 months
|
|
Infections and infestations
Infection-Other (specify) tinea pedis, left foot
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection - sexual/reproductive function - vulva
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection w/neutropenia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection without neutropenia
|
13.3%
4/30 • Number of events 4 • 16.5 months
|
|
Infections and infestations
Infection, C. diff & rota virus
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection, CVL
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection, influenza (w/o neutropenia)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection, musculo-skeletal, soft tissue
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection: Febrile neutropenia
|
16.7%
5/30 • Number of events 5 • 16.5 months
|
|
Infections and infestations
Infection: Infection
|
16.7%
5/30 • Number of events 5 • 16.5 months
|
|
Infections and infestations
Infection: Infection (documented clinically or microbiologically)
|
13.3%
4/30 • Number of events 5 • 16.5 months
|
|
Infections and infestations
Infection: Infection with normal ANC or Grade 1 or 2 neutrophils:
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: select - conjunctiva
|
13.3%
4/30 • Number of events 8 • 16.5 months
|
|
Infections and infestations
Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: skin
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: skin (cellulitis)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: upper airway NOS
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Abdominal cramping
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Abscesses (crypt)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Acne breakout
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Adenopathy
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Agitated mental status
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Hepatobiliary disorders
Albumin low
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Hepatobiliary disorders
Alk. phosph.
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Immune system disorders
Allergic rhinitis-rhinorrhea
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Immune system disorders
Allergy/Immunology: Allergic reaction/hypersensitivity (including drug fever)
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Immune system disorders
Allergy/Immunology: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
60.0%
18/30 • Number of events 60 • 16.5 months
|
|
Immune system disorders
Allergy/Immunology: Autoimmune reaction
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Gastrointestinal disorders
Appetite decreased
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
4/30 • Number of events 5 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Bacteremia
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Bilious emesis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Bilious vomiting
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow:Platelets
|
86.7%
26/30 • Number of events 375 • 16.5 months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow:Hemoglobin
|
100.0%
30/30 • Number of events 393 • 16.5 months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow:Leukocytes (total WBC)
|
90.0%
27/30 • Number of events 241 • 16.5 months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow:Neutrophils/granulocytes (ANC/AGC)
|
86.7%
26/30 • Number of events 235 • 16.5 months
|
|
Eye disorders
Blurred vision
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Ear and labyrinth disorders
Bullous myringitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Injury, poisoning and procedural complications
Burn
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Injury, poisoning and procedural complications
Burns, radiation
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Cardiac Arrhythmia: Supraventricular and nodal arrhythmia - Sinus tachycardia
|
23.3%
7/30 • Number of events 13 • 16.5 months
|
|
Cardiac disorders
Cardiac General: Hypertension
|
23.3%
7/30 • Number of events 16 • 16.5 months
|
|
Cardiac disorders
Cardiac General:Hypotension
|
30.0%
9/30 • Number of events 20 • 16.5 months
|
|
General disorders
Chills
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Cardiac disorders
Compression of vena cava by tumor
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Immune system disorders
Congestion
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
General disorders
Constitutional Symptoms - Other (pallor)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Constitutional Symptoms: Fatigue (asthenia, lethargy, malaise)
|
66.7%
20/30 • Number of events 43 • 16.5 months
|
|
General disorders
Constitutional Symptoms: Fever
|
66.7%
20/30 • Number of events 55 • 16.5 months
|
|
General disorders
Constitutional Symptoms: Insomnia
|
20.0%
6/30 • Number of events 11 • 16.5 months
|
|
General disorders
Constitutional Symptoms: Weight loss
|
20.0%
6/30 • Number of events 11 • 16.5 months
|
|
Renal and urinary disorders
Creatinine
|
13.3%
4/30 • Number of events 4 • 16.5 months
|
|
Gastrointestinal disorders
Dehydration
|
13.3%
4/30 • Number of events 4 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Pigmentation changes
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Dermatology/Skin-Other (lip abrasion)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Dermatology/Skin-Other (specify: verrucae)
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Dry skin
|
30.0%
9/30 • Number of events 29 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Rash/dermatitis associated with high dose chemotherapy or BMT studies
|
3.3%
1/30 • Number of events 11 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Rash: acne
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
20.0%
6/30 • Number of events 14 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Dermatology/Skin-Other (specify, keratosis pilaris)
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Hypopigmentation
|
10.0%
3/30 • Number of events 10 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Nail changes
|
6.7%
2/30 • Number of events 5 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Photosensitivity
|
3.3%
1/30 • Number of events 4 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Rash/desquamation
|
50.0%
15/30 • Number of events 130 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Rash/desquamation associated with graft versus host disease (GVHD)
|
16.7%
5/30 • Number of events 28 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Rash: dermatitis associated with radiation-select: radiation
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Striae
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Desquamation of palmar surface of hands, B/L
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Desquamation, vaginal
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Diaphoresis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Eye disorders
Diplopia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Dyspareunia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Dysphagia
|
13.3%
4/30 • Number of events 4 • 16.5 months
|
|
Nervous system disorders
Dystonia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Renal and urinary disorders
Dysuria
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Ear and labyrinth disorders
Ears-dry
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Edema, extremities
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Emesis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Endocrine disorders
Endocrine: Cushingoid appearance
|
30.0%
9/30 • Number of events 29 • 16.5 months
|
|
Infections and infestations
Infection-upper respiratory symptoms
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Infiltrate (lung)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Intermittent headache
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Itching (anal warts)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Joint soreness, intermittent
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness & pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Low energy level
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Low grade fever
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Blood and lymphatic system disorders
Lymphatics
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Lymphatics: edema: limb
|
16.7%
5/30 • Number of events 8 • 16.5 months
|
|
Blood and lymphatic system disorders
Lymphocytes
|
13.3%
4/30 • Number of events 4 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Macular rash
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Macular rash on anterior and posterior chest
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Bilirubin, serum-high (hyperbilirubinemia)
|
70.0%
21/30 • Number of events 134 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Other (Urea nitrogen, low???)
|
26.7%
8/30 • Number of events 27 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Cholesterol, serum high (hypercholestremia)
|
20.0%
6/30 • Number of events 23 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: AST, SGOT (serum glutamic oxaloacetic)
|
80.0%
24/30 • Number of events 253 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Calcium, serum-low (hypocalcemia)
|
80.0%
24/30 • Number of events 163 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Glucose, serum-high (hyperglycemia)
|
90.0%
27/30 • Number of events 408 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Glucose, serum-low (hypoglycemia)
|
26.7%
8/30 • Number of events 14 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Magnesium, serum-high (hypermagnesemia)
|
50.0%
15/30 • Number of events 43 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Magnesium, serum-low (hypomagnesemia)
|
73.3%
22/30 • Number of events 153 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Potassium, serum-high (hyperkalemia)
|
30.0%
9/30 • Number of events 14 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Sodium, serum-low (hyponatremia)
|
83.3%
25/30 • Number of events 165 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Triglyceride, serum-high (hypertriglyceridemia)
|
26.7%
8/30 • Number of events 36 • 16.5 months
|
|
Metabolism and nutrition disorders
Mg, low
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Gastrointestinal disorders
Mucositis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Mild constipation
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Mild cough
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Immune system disorders
Mild nasal congestion
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Mild neuropathy of right foot
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Mild tenderness in lumbosacral area
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Molluscum rash to upper thighs B/L
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Mood alteration - anxiety
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Nervous system disorders
Mood alteration-depression
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Muscle aches-back, hip, left neck, right lateral chest wall, right scapular
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/other-joint stiffness
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: joint-effusion
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Muscle weakness, genralized or specific area
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Fracture
|
6.7%
2/30 • Number of events 7 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Muscle weakness, generalized or specific area (not due to neuropathy):
|
6.7%
2/30 • Number of events 7 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Musculoskeletal/Soft tissue - Other
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Osteonecrosis (avascular necrosis)
|
6.7%
2/30 • Number of events 6 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia-Muscle cramps
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Neurology: Mood alteration: agitation
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
Nervous system disorders
Neurology: mood alteration: anxiety
|
30.0%
9/30 • Number of events 21 • 16.5 months
|
|
Nervous system disorders
Neurology: mood alteration: depression
|
40.0%
12/30 • Number of events 27 • 16.5 months
|
|
Nervous system disorders
Neurology: neuropathy: cranial - select neuropathy: CN XII motor- tongue
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Neurology: neuropathy: sensory
|
23.3%
7/30 • Number of events 20 • 16.5 months
|
|
Nervous system disorders
Neurology: seizure
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
Nervous system disorders
Neurology: tremor
|
30.0%
9/30 • Number of events 19 • 16.5 months
|
|
Nervous system disorders
Neuropathy
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Eye disorders
Ocular/Visual: dry eye syndrome
|
6.7%
2/30 • Number of events 9 • 16.5 months
|
|
Eye disorders
Ocular/Visual: cataract
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Eye disorders
Ocular/Visual: Ocular/Visual - Other (specify, erythema)
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Eye disorders
Ocular/Visual: Vision-blurred vision
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Oral candidiasis
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Gastrointestinal disorders
Oral pain, esophageal pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Other, edema
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Other, fluid overload
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Other, sixth nerve palsy
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Pain
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
General disorders
Pain, head
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Pain mouth sore
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Pain perianal
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Pain thoracic
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Pain, abdominal
|
26.7%
8/30 • Number of events 9 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain, chest
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain, extremities (throbbing)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Pain, Headache
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain, knee
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain, left trapezius and shoulder area
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain, myalgia
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Gastrointestinal disorders
Pain, oral mucosa
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Ear and labyrinth disorders
Pain, ear
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain, musculoskeletal
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain, tenderness (chest)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Ear and labyrinth disorders
pain/auditory/ear: external
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Coagulation: PTT (partial thromboplastin time)
|
93.3%
28/30 • Number of events 159 • 16.5 months
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Pain/Gastrointestinal:dental/teeth/periodontal
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain/Musculoskeletal:Back
|
26.7%
8/30 • Number of events 20 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain/Musculoskeletal:Extremity-limb
|
30.0%
9/30 • Number of events 26 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain/Musculoskeletal:Bone
|
10.0%
3/30 • Number of events 5 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain/Musculoskeletal:Buttock
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain/Musculoskeletal:Neck
|
10.0%
3/30 • Number of events 4 • 16.5 months
|
|
Nervous system disorders
Pain/Neurology:Head/Headache
|
20.0%
6/30 • Number of events 12 • 16.5 months
|
|
Eye disorders
Pain/Ocular: eye
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain/Pulmonary/Upper Respiratory: Chest/thorax NOS
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain/Pulmonary/Upper Respiratory:Chest wall
|
16.7%
5/30 • Number of events 6 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain/Pulmonary/Upper Respiratory:Pleura
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain/Pulmonary/Upper Respiratory:Sinus
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain:Chest wall
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain: pleuritic
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Reproductive system and breast disorders
Pain:vaginally
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Pain:Gastrointestinal: oral cavity
|
10.0%
3/30 • Number of events 8 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Papular rash hands
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Paronychia, hallux, B/L
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Peeling-bilateral palms
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Pericardial fluid
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Poor appetite
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Infections and infestations
Positive viral culture
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Proctitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Renal and urinary disorders
Proteinuria
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Psychiatric disorders
Psychotic episode
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
PT, prolonged
|
26.7%
8/30 • Number of events 8 • 16.5 months
|
|
Blood and lymphatic system disorders
RBC transfusion
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Rectal pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, other, tachypnea
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Sweating
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Swelling
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Hepatobiliary disorders
Transaminitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Transfusion, platelet
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Ulcer, duodenal
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Ulcers near molars
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Renal and urinary disorders
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Eye disorders
Uveitis, OU
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Vertigo (sensation)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Visual hallucination
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
9/30 • Number of events 9 • 16.5 months
|
|
Eye disorders
Xeropthalmia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: Dermatology-Skin
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Potassium, serum-low (hypokalemia)
|
33.3%
10/30 • Number of events 26 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Musculoskeletal - Joint
|
23.3%
7/30 • Number of events 11 • 16.5 months
|
|
General disorders
Pain: NOS
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Ear and labyrinth disorders
Pain: Pain: Auditory/Ear
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain-ankles & knees
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
13.3%
4/30 • Number of events 4 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain - chest
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Eye disorders
Pain - left eye
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Eye disorders
Pain - right eye
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain - scapular
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain - skull
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pansinusitis
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Patchy erythema, upper and lower extremities, palms and soles, B/L
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Perianal pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Metabolism and nutrition disorders
Phosphatemia
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Post-nasal drainage
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
13.3%
4/30 • Number of events 4 • 16.5 months
|
|
Metabolism and nutrition disorders
Protein low
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary effusion
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary emboli
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Other
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Atelectasis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Hypoxemia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Pneumothorax
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Radiation Dermatits
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash - erythematous, mild, lacy
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash - trunk, arms, face, legs, sparing feet
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash (Acne)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash (maculopapular) GVHD
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash (port erythema)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash, B/L LEs and UEs
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash, erythematous (GVHD)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash, palmar surface
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash, erythema
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash - chest & palms of hands
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Rash - soles
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Right hip - slightly limited range of motion
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Rigors
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Sacro-iliac pain, right side
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Sensitive teeth
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Severe fatigue
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Skin fibrosis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Skin lesions
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Sleepiness
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Small bowel obstruction
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
6/30 • Number of events 6 • 16.5 months
|
|
Gastrointestinal disorders
Stomatitis, candida
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Tachycardia
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Cardiac disorders
Tachypnea
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Eye disorders
Tearing
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Tenderness
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Vascular disorders
Thrombophlebitis, superficial, B/L
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Metabolism and nutrition disorders
Total bilirubin, high
|
16.7%
5/30 • Number of events 5 • 16.5 months
|
|
Blood and lymphatic system disorders
Transfusion, RBC
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Ulceration on right buccal mucosa
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Reproductive system and breast disorders
Vaginal irritation
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Vascular disorders
Vascular: thrombosis/thrombus/embolism
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Eye disorders
Visual changes
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Immune system disorders
Allergy/Immunology: Allergic rhinitis
|
6.7%
2/30 • Number of events 8 • 16.5 months
|
|
Blood and lymphatic system disorders
Ankle edema B/L
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Ankle swelling, bilaterally
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Anxiety
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Ear and labyrinth disorders
Auditory/Ear: Hearing
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Ear and labyrinth disorders
Auditory/Hearing: External auditory canal
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow:CD4 Count
|
3.3%
1/30 • Number of events 4 • 16.5 months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow:Haptoglobin
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
General disorders
BMT Complex/Multicomponent Events: Graft versus host disease
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
C. difficile colitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Cardiac Arrhythmia - Prolonged QTc interval
|
6.7%
2/30 • Number of events 7 • 16.5 months
|
|
Cardiac disorders
Cardiac Arrhythmia: Supraventricular and nodal arrhythmia - Sinus bradycardia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Cardiac Arrhythmia: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
6.7%
2/30 • Number of events 4 • 16.5 months
|
|
Cardiac disorders
Cardiac General: Other, capillary leak syndrome
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Cardiac disorders
Cardiac General: Pericardial effusion (non-malignant)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Cardiovascular (Arrhythmia): Sinus bradycardia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Cardiac disorders
Cardiovascular General: Cardiac left ventricular function
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Cardiac disorders
Cardiovascular/General: Other (Specify, venous valve)
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Metabolism and nutrition disorders
Cholesterol
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Coagulation: Other (Specify, bruising to lower extremities)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Coagulation: INR (International Normalized Ration of prothrombin time)
|
23.3%
7/30 • Number of events 29 • 16.5 months
|
|
Blood and lymphatic system disorders
Coagulation: Other (Specify, positive lupus anticoagulant)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Coagulation: thrombotic microangiopathy
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
General disorders
Constitutional Symptoms: Rigors/Chills
|
13.3%
4/30 • Number of events 5 • 16.5 months
|
|
General disorders
Constitutional Symptoms: Sweating (diaphoresis)
|
10.0%
3/30 • Number of events 6 • 16.5 months
|
|
General disorders
Constitutional Symptoms: Weight gain
|
6.7%
2/30 • Number of events 8 • 16.5 months
|
|
Renal and urinary disorders
Cystitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Death: Death not associated with CTCAE term: Disease progression NOS
|
13.3%
4/30 • Number of events 4 • 16.5 months
|
|
Gastrointestinal disorders
Dental caries
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Bruising
|
6.7%
2/30 • Number of events 12 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Hand-foot skin reaction
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Chelitis
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Hair loss/alopecia (scalp or body)
|
36.7%
11/30 • Number of events 47 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Injection site reaction/extravasation changes
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Other
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Pruritis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Pruritis/itching
|
13.3%
4/30 • Number of events 9 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Radiation dermatitis
|
3.3%
1/30 • Number of events 7 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Rash: acne/acneiform
|
20.0%
6/30 • Number of events 24 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Rash: dermatitis
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Skin breakdown/decubitus ulcer
|
10.0%
3/30 • Number of events 6 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Ulceration
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Urticaria (hives, welts, wheals)
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin: Bruising (in absence of Grade 3
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatology: Hypopigmentation
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Endocrine disorders
Endocrine: Hot flashes/Flushes
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Flexion contracture, left knee (musculoskeletal, other)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Endocrine disorders
Endocrine: Other (Specify, secondary ovarian failure)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Other (Specify, early satiety)
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Distention/bloating
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Mucositis/stomatitis - Oral cavity
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Ascites (non-malignant)
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Dehydration
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Colitis
|
10.0%
3/30 • Number of events 4 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:
|
6.7%
2/30 • Number of events 4 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Dysphagia (difficulty swallowing)
|
10.0%
3/30 • Number of events 5 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Esophagitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Gastritis (including bile reflux gastritis)
|
6.7%
2/30 • Number of events 4 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
6.7%
2/30 • Number of events 9 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Other
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal:other, specify::Cholestasis
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Proctitis
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Vomiting
|
16.7%
5/30 • Number of events 8 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Abdominal pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Constipation
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Dental:Teeth
|
3.3%
1/30 • Number of events 4 • 16.5 months
|
|
Gastrointestinal disorders
Gastrointestinal: Nausea
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Hematochezia/rectal bleeding
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding: Hematoma
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Renal and urinary disorders
Hemorrhage/Bleeding: Hemorrhage, GU::Urinary NOS
|
6.7%
2/30 • Number of events 8 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage/Bleeding: Hemorrhage, pulmonary/upper respiratory::Nose
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Blood and lymphatic system disorders
Hemorrhage::Rectal bleeding/hematochezia
|
6.7%
2/30 • Number of events 5 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Hemorrhage: Petechiae
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Hepatobiliary disorders
Hepatic: Albumin, serum-low (hypoalbuminemia)
|
6.7%
2/30 • Number of events 4 • 16.5 months
|
|
Hepatobiliary disorders
Hepatic:Bilirubin (hyperbilirubinemia)
|
3.3%
1/30 • Number of events 4 • 16.5 months
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas:: Cholecystitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas:: Pancreatitis
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Gastrointestinal disorders
Increased perirectal pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection: Other
|
6.7%
2/30 • Number of events 4 • 16.5 months
|
|
Infections and infestations
Infection - Other (Specify, abrasion right great toe)
|
3.3%
1/30 • Number of events 12 • 16.5 months
|
|
Infections and infestations
Infection - Select - Renal/Genitourinary-kidney
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection General::Wound
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection/Febrile neutropenia::Infection
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection::Infection (documented clincally or micro) with grade 3 or 4 neutrophils
|
10.0%
3/30 • Number of events 3 • 16.5 months
|
|
Infections and infestations
Infection::Colitis, infectious (e.g., Clostridium difficile)
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
Infections and infestations
Infection::Infection
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection::Infection with normal ANC or Grade 1 or 2 neutrophils::Gluteal abscess left side
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection::Infection with normal ANC or Grade 1 or 2 neutrophils::Sinusitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection::Infection with unknown ANC::Lung (pneumonia)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection::Infection with unknown ANC::Urinary tract NOS
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Infections and infestations
Infection::Opportunistic infection associated with > grade 2 lymphopenia
|
3.3%
1/30 • Number of events 6 • 16.5 months
|
|
Infections and infestations
Infection::Infection - Other (Specify, clostridium difficile)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Renal and urinary disorders
Interstitial nephritis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Left hip pain/left groin pain (musculoskeletal)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Lymphatics::Edema:head and neck
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Blood and lymphatic system disorders
Lymphatics::Lymphatics - Other (Specify, palpable inguinal adenopathy)
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Blood and lymphatic system disorders
Lymphedema, left LE
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Albumin, serum-low (hypoalbuminemia)
|
43.3%
13/30 • Number of events 195 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Other, (Specify, BUN, high)
|
10.0%
3/30 • Number of events 6 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Alkaline phosphatase
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: ALT, SGPT (serum glutamic pyruvic transaminase)
|
36.7%
11/30 • Number of events 209 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Calcium, serum-high (hypercalcemia)
|
13.3%
4/30 • Number of events 7 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Creatinine
|
16.7%
5/30 • Number of events 17 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Hemogloginuria
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Metabolic/Laboratory: Other, (Specify, LDH)
|
66.7%
20/30 • Number of events 163 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Phosphate, serum-low (hypophosphatemia)
|
20.0%
6/30 • Number of events 32 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory:Potassium, serum-low (hypokalemia)
|
36.7%
11/30 • Number of events 102 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Proteinuria
|
23.3%
7/30 • Number of events 42 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Sodium, serum-high (hypernatremia)
|
20.0%
6/30 • Number of events 12 • 16.5 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory: Other, urine protein
|
10.0%
3/30 • Number of events 12 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Mild erythema (IV access site)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Mild fatigue
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Mucositis of throat and rectal area
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Mult. abdominal ecchymosis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Cervical spine-range of motion
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Extremity-lower
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Extremity-lower (gait/walking)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Muscle weakness
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue: Muscular/Skeletal hypoplasia
|
3.3%
1/30 • Number of events 6 • 16.5 months
|
|
Nervous system disorders
Neurology: Extrapyramidal/involuntary movement/restlessness
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Neurology:Ataxia (incoordination)
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Nervous system disorders
Neurology: Confusion
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Nervous system disorders
Neurology: Insomnia
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Nervous system disorders
Neurology: neuropathy: motor
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Nervous system disorders
Neurology: other
|
3.3%
1/30 • Number of events 4 • 16.5 months
|
|
Eye disorders
Ocular/Visual:Dry eyes
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
General disorders
Pain - Other (Specify, pain at site of biopsy)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Other: Breathing
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
General disorders
Pain - right lateral
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Renal and urinary disorders
Pain - Select: Renal/Genitourinary - Kidney
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
General disorders
Pain - Other
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Pain with defecation
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Pain/Dermatology/Skin::Face
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Pain/Dermatology/Skin::Oral
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Pain/Gastrointestinal::Abdomen NOS
|
30.0%
9/30 • Number of events 39 • 16.5 months
|
|
General disorders
Pain/General::Tumor pain
|
3.3%
1/30 • Number of events 4 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain/Musculoskeletal::Extremity-limb, upper
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal::Muscle
|
13.3%
4/30 • Number of events 22 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain/Musculoskeletal::Oral cavity
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain/Myalgia (Muscle pain)
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Nervous system disorders
Pain/Neurology::Neuralgia/peripheral nerve
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain/Pulmonary/Upper Respiratory::Throat/pharynx/Larynx
|
16.7%
5/30 • Number of events 18 • 16.5 months
|
|
Reproductive system and breast disorders
Pain/Sexual/Reproductive Function::Urethra
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain:Arthralgia (joint pain)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Ear and labyrinth disorders
Pain:Earache
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Pain:General
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain:Musculoskeletal - Joint
|
10.0%
3/30 • Number of events 5 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain:Other back
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Other hip
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Other leg
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Other neck
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Other upper right quadrant
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Reproductive system and breast disorders
Pain: Pelvis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain:Tumor
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Pain:Dermatology/Skin - Oral gums
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Pain: Gastrointestinal - Anus
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
General disorders
Pain::General - Tumor pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Injury, poisoning and procedural complications
Pain::Pain - Other (Specify, surgical incision pain)
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Reproductive system and breast disorders
Pain::Pain - Select: Sexual/Reproductive Function - Scrotum
|
3.3%
1/30 • Number of events 8 • 16.5 months
|
|
Gastrointestinal disorders
Pain::Pain:: Abdomen NOS
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Pain::Back
|
16.7%
5/30 • Number of events 12 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Pain::Bone
|
16.7%
5/30 • Number of events 17 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Pain::Chest wall
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Pain::Chest/thorax NOS
|
6.7%
2/30 • Number of events 3 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Pain::Extremity-limb
|
13.3%
4/30 • Number of events 5 • 16.5 months
|
|
Nervous system disorders
Pain::Pain::Head/headache
|
10.0%
3/30 • Number of events 8 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Pain::Muscle
|
16.7%
5/30 • Number of events 15 • 16.5 months
|
|
Gastrointestinal disorders
Pain::Pain::Oral cavity
|
6.7%
2/30 • Number of events 5 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Pain::Paraspinal
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Gastrointestinal disorders
Pain::Pain::Throat/pharynx/larynx
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Nervous system disorders
Pain::Head/headache
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Pain::Rectal or perirectal pain (Proctalgia)
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Perirectal pain
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Gastrointestinal disorders
Proctitis/perirectal skin breakdown
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory::Bronchospasm, wheezing
|
16.7%
5/30 • Number of events 8 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Cough
|
60.0%
18/30 • Number of events 40 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory:Dyspnea (shortness of breath)
|
33.3%
10/30 • Number of events 14 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Fev1
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Hypoxia
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Nasal cavity/paranasal sinus reactions
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory:pleural effusion (non-malignant)
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Pneumonitis/pulmonary infiltrates
|
10.0%
3/30 • Number of events 5 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory: Pulmonary/Upper Respiratory: Other (Specify, crackles)
|
10.0%
3/30 • Number of events 5 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Pulmonary Other
|
3.3%
1/30 • Number of events 5 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary:Dyspnea
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Radiodermatitis, right lateral leg
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Renal and urinary disorders
Renal/Genitourinary::Dysuria
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Renal and urinary disorders
Renal/Genitourinary::Obstruction, GU::Ureter
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Renal and urinary disorders
Renal/Genitourinary::Stricture/Stenosis, GU - Select, left hydronephrosis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Renal and urinary disorders
Renal/Genitourinary::Urinary frequency/urgency
|
3.3%
1/30 • Number of events 2 • 16.5 months
|
|
Renal and urinary disorders
Renal/Genitourinary::Urinary retention
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Immune system disorders
Rhinorrhea
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Erectile dysfunction
|
6.7%
2/30 • Number of events 9 • 16.5 months
|
|
Reproductive system and breast disorders
Sexual/Reproductive::Other
|
3.3%
1/30 • Number of events 3 • 16.5 months
|
|
Musculoskeletal and connective tissue disorders
Sore rib cage on left side
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
2/30 • Number of events 2 • 16.5 months
|
|
Gastrointestinal disorders
Ulcerations - soft palate
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Renal and urinary disorders
URI/Sinusitis
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Vascular disorders
Vascular::Vessel injury - vein-Select:Other NOS
|
3.3%
1/30 • Number of events 4 • 16.5 months
|
|
Skin and subcutaneous tissue disorders
Verrucae
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Low grade fevers
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary emboli, B/L
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
Infections and infestations
Infection: General, catheter related
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
|
General disorders
Death
|
3.3%
1/30 • Number of events 1 • 16.5 months
|
Additional Information
Dr. Terry Fry
National Cancer Institute, National Institutes of Health
Phone: 301-402-0215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place