Trial Outcomes & Findings for Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer (NCT NCT00006011)
NCT ID: NCT00006011
Last Updated: 2015-05-19
Results Overview
Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion. Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization. Intention to treat among eligible participants who receive random treatment allocation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
659 participants
Primary outcome timeframe
study entry up to 5 years post treatment
Results posted on
2015-05-19
Participant Flow
All patients were initially registered and initiated radiation treatment. Following succsessful completion of radiation treatment, participants with no evidence of disease received a random treatment allocation.
Participant milestones
| Measure |
Arm 1
Treatment randomization following RT.
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11
|
Arm 2
Treatment randomization following RT:
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12
|
Radiation (RT) Only
Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
|
|---|---|---|---|
|
Overall Study
STARTED
|
288
|
298
|
73
|
|
Overall Study
COMPLETED
|
223
|
221
|
0
|
|
Overall Study
NOT COMPLETED
|
65
|
77
|
73
|
Reasons for withdrawal
| Measure |
Arm 1
Treatment randomization following RT.
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11
|
Arm 2
Treatment randomization following RT:
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12
|
Radiation (RT) Only
Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
|
|---|---|---|---|
|
Overall Study
Disease progression
|
13
|
6
|
26
|
|
Overall Study
Refused further treatment
|
15
|
13
|
26
|
|
Overall Study
Adverse Event
|
15
|
39
|
5
|
|
Overall Study
Death
|
0
|
1
|
2
|
|
Overall Study
Other
|
4
|
2
|
5
|
|
Overall Study
Ineligible
|
18
|
16
|
9
|
Baseline Characteristics
Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=270 Participants
Treatment randomization following RT.
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11
|
Arm 2
n=282 Participants
Treatment randomization following RT:
radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12
|
Radiation (RT) Only
n=64 Participants
Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
|
Total
n=616 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
58.8 years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
63.9 years
STANDARD_DEVIATION 10.7 • n=206 Participants
|
59.3 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
270 Participants
n=99 Participants
|
282 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
616 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: study entry up to 5 years post treatmentRecurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion. Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization. Intention to treat among eligible participants who receive random treatment allocation.
Outcome measures
| Measure |
Arm 1
n=270 Participants
Treatment randomization following RT.
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11
|
Arm 2
n=282 Participants
Treatment randomization following RT:
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12
|
|---|---|---|
|
Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.
Recurrence or Death
|
111 participants
|
107 participants
|
|
Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.
Alive, Recurrence-Free
|
159 participants
|
175 participants
|
Adverse Events
Arm 1
Serious events: 10 serious events
Other events: 259 other events
Deaths: 0 deaths
Arm 2
Serious events: 21 serious events
Other events: 278 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=261 participants at risk
Treatment randomization following RT.
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11
|
Arm 2
n=278 participants at risk
Treatment randomization following RT:
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12
|
|---|---|---|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Nervous system disorders
Cns Cerebrovascular Ischemia
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Blood and lymphatic system disorders
Neutrophils/Granulocytes
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
1.1%
3/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Cardiac disorders
Circulatory or Cardia, Other
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Cardiac disorders
Vasovagal Episode
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.72%
2/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Cardiac disorders
Cardia-Ischemia/Infarction
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
General disorders
Fatigue
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
General disorders
Abdominal Pain or Cramping
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
General disorders
Pain, Other
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Skin and subcutaneous tissue disorders
Wound-Infectious
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.00%
0/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.00%
0/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Gastrointestinal disorders
Anorexia
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.00%
0/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Gastrointestinal disorders
Diarrhea (without Colostomy)
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.72%
2/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Infections and infestations
Infection, Other
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.00%
0/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Infections and infestations
Infection Documented with Grade 3/4 Neutropenia
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Infections and infestations
Infection without Neutropenia
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.00%
0/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Infections and infestations
Febrile Neutropenia-Fuo Infection Not Documented
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.00%
0/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (Avascular Necrosis)
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.00%
0/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Nervous system disorders
Syncope
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.00%
0/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Nervous system disorders
Neuropathy-Sensory
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
0.36%
1/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Vascular disorders
Thrombosis/Embolism
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
1.4%
4/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
Other adverse events
| Measure |
Arm 1
n=261 participants at risk
Treatment randomization following RT.
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11
|
Arm 2
n=278 participants at risk
Treatment randomization following RT:
doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
72.8%
190/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
89.9%
250/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
60.5%
158/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
84.9%
236/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.1%
55/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
41.7%
116/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
52.5%
137/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
73.7%
205/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Blood and lymphatic system disorders
Other Hematologic
|
16.9%
44/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
25.5%
71/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Immune system disorders
Allergy
|
1.5%
4/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
2.9%
8/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Ear and labyrinth disorders
Auditory
|
6.1%
16/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
2.9%
8/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Cardiac disorders
Cardiac left ventricular function
|
10.7%
28/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
8.6%
24/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Cardiac disorders
Other Cardiovascular
|
11.1%
29/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
15.8%
44/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Cardiac disorders
Coagulation
|
0.00%
0/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
1.4%
4/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
General disorders
Constitutional
|
40.2%
105/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
47.8%
133/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
70.9%
185/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
64.4%
179/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Skin and subcutaneous tissue disorders
Other Dermatologic
|
5.7%
15/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
6.1%
17/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Endocrine disorders
Endocrine
|
6.5%
17/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
5.0%
14/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Gastrointestinal disorders
Nausea
|
34.1%
89/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
34.2%
95/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Gastrointestinal disorders
Vomiting
|
28.7%
75/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
28.4%
79/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
4.2%
11/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
5.4%
15/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Gastrointestinal disorders
Other Gastrointestinal
|
28.0%
73/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
31.7%
88/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Renal and urinary disorders
Genitourinary/Renal
|
6.9%
18/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
9.7%
27/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Vascular disorders
Hemorrhage
|
0.77%
2/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
1.8%
5/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Renal and urinary disorders
Hepatic
|
2.3%
6/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
5.0%
14/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.38%
1/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
6.1%
17/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Infections and infestations
Infection Without Neutropenia
|
9.6%
25/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
11.5%
32/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Infections and infestations
Other Infection/Fever
|
4.2%
11/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
12.6%
35/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Blood and lymphatic system disorders
Lymphatics
|
1.9%
5/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
1.8%
5/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Metabolism and nutrition disorders
Metabolic
|
17.6%
46/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
19.8%
55/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
4.2%
11/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
9.4%
26/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Nervous system disorders
Peripheral Sensory Neurologic
|
5.0%
13/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
27.3%
76/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Nervous system disorders
Other Neurologic
|
11.9%
31/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
18.7%
52/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Eye disorders
Ocular/Visual
|
4.2%
11/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
4.0%
11/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
7/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
18.7%
52/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
General disorders
Other Pain
|
24.1%
63/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
36.3%
101/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
11.9%
31/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
14.0%
39/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Reproductive system and breast disorders
Sexual
|
1.1%
3/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
1.8%
5/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Primary
|
5.4%
14/261 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
6.5%
18/278 • The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.
Serious Adverse Events(SAE) are reported separately. Due to the methods in which AEs were collected \&/or stored, it isn't possible to report Other AEs separate from SAEs. That table is a combined set of SAEs \& non-serious AEs. Other AEs are acute, grade 2 or worse AEs that occured during chemotherapy treatmentand don't include late AEs.
|
Additional Information
Angela M. Kuras, Associate Director of Data Management
NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place