Trial Outcomes & Findings for Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus (NCT NCT00476086)
NCT ID: NCT00476086
Last Updated: 2018-08-24
Results Overview
Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
Results posted on
2018-08-24
Participant Flow
20 participants were enrolled between May 2007 and August 2011.
Participant milestones
| Measure |
Oxaliplatin/ Gemcitabine Then Radiation
Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
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|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
Received Chemotherapy
|
19
|
|
Overall Study
Received Radiation
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Oxaliplatin/ Gemcitabine Then Radiation
Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
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|---|---|
|
Overall Study
Alternative therapy
|
1
|
|
Overall Study
Progressive Disease
|
4
|
Baseline Characteristics
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
Baseline characteristics by cohort
| Measure |
Oxaliplatin/ Gemcitabine Then Radiation
n=20 Participants
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
on
|
|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 cycles of chemotherapy which approximates 3 months given the 28-day cyclePopulation: The analysis dataset is comprised of all participants who started chemotherapy.
Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.
Outcome measures
| Measure |
Oxaliplatin/ Gemcitabine Then Radiation
n=19 Participants
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
|
|---|---|
|
Chemotherapy Completion Rate
|
100 percentage of participants
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.Population: The analysis dataset is comprised of all participants who started chemotherapy.
Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease
Outcome measures
| Measure |
Oxaliplatin/ Gemcitabine Then Radiation
n=19 Participants
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
|
|---|---|
|
Radiation Therapy Completion Rate
|
79 percentage of participants
Interval 58.0 to 92.0
|
Adverse Events
Radiation
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Oxaliplatin/ Gemcitabine
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation
n=15 participants at risk
On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
|
Oxaliplatin/ Gemcitabine
n=19 participants at risk
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.
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|---|---|---|
|
Infections and infestations
Infection Gr0-2 neut, colon
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Investigations
ALT, SGPT
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
Other adverse events
| Measure |
Radiation
n=15 participants at risk
On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
|
Oxaliplatin/ Gemcitabine
n=19 participants at risk
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.
|
|---|---|---|
|
Gastrointestinal disorders
Abdomen, pain
|
20.0%
3/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Immune system disorders
Allergic reaction
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
10.5%
2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Investigations
ALT, SGPT
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
2/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Investigations
AST, SGOT
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
42.1%
8/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
General disorders
Constitutional, other
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
10.5%
2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
73.3%
11/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
10.5%
2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
15.8%
3/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
General disorders
Edema limb
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
General disorders
Fatigue
|
60.0%
9/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
73.7%
14/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
GI-other
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
10.5%
2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Nervous system disorders
Head/headache
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
Hemorrhoids
|
20.0%
3/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Vascular disorders
Hot flashes
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Infections and infestations
Infection w/ gr3-4 neut, anal/perianal
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Infections and infestations
Infection-other
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
General disorders
Injection site reaction
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
15.8%
3/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Investigations
Leukocytes
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
10.5%
2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
15.8%
3/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
52.6%
10/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Nervous system disorders
Neurologic-other
|
33.3%
5/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
63.2%
12/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Nervous system disorders
Neuropathy-sensory
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
47.4%
9/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Investigations
Neutrophils
|
13.3%
2/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
General disorders
Pain NOS
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
General disorders
Pain-other
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Investigations
Platelets
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
10.5%
2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
33.3%
5/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.3%
2/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
10.5%
2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
Rectum, pain
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
General disorders
Rigors/chills
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Skin and subcutaneous tissue disorders
Skin, pain
|
13.3%
2/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
5.3%
1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
10.5%
2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Nervous system disorders
Taste disturbance
|
0.00%
0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
10.5%
2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
0.00%
0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
|
21.1%
4/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place