Trial Outcomes & Findings for Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer (NCT NCT01060007)
NCT ID: NCT01060007
Last Updated: 2017-03-08
Results Overview
T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
Results posted on
2017-03-08
Participant Flow
The study opened to participant enrollment on 11/10/2009 and closed to participant enrollment on 04/18/2012.
Participant milestones
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
76
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Inevaluable for response at surgery
|
3
|
Baseline Characteristics
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=76 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
|
Clinical T stage
cT3
|
69 participants
n=5 Participants
|
|
Clinical T stage
cT4
|
7 participants
n=5 Participants
|
|
Clinical N stage
cN0
|
17 participants
n=5 Participants
|
|
Clinical N stage
cN+
|
59 participants
n=5 Participants
|
|
Clinical M stage
cM0
|
69 participants
n=5 Participants
|
|
Clinical M stage
cM1
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
Outcome measures
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=76 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
Pre-surgery
|
1 Year Post-treatment
|
|---|---|---|---|
|
Rate of T Stage Downstaging
|
71 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)Population: One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.
As measured by participants who experience grade 3 or higher gastrointestinal morbidity
Outcome measures
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=79 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
Pre-surgery
|
1 Year Post-treatment
|
|---|---|---|---|
|
Preoperative Gastrointestinal Morbidity
|
7 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)Population: One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.
Outcome measures
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=79 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
Pre-surgery
|
1 Year Post-treatment
|
|---|---|---|---|
|
Incidence of Any Late Grade 3 or Higher Morbidity
Non-hematologic toxicities
|
16 participants
|
—
|
—
|
|
Incidence of Any Late Grade 3 or Higher Morbidity
Hematologic toxicities
|
21 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year (completion of all treatment)Outcome measures
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=76 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
Pre-surgery
|
1 Year Post-treatment
|
|---|---|---|---|
|
Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity
|
21 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 months* Kaplan-Meier projections * Local control = control of primary tumor
Outcome measures
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=76 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
Pre-surgery
|
1 Year Post-treatment
|
|---|---|---|---|
|
Local Control
|
95 percentage of participants
Interval 89.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=76 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
Pre-surgery
|
1 Year Post-treatment
|
|---|---|---|---|
|
Rate of Overall Control
|
89 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=76 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
Pre-surgery
|
1 Year Post-treatment
|
|---|---|---|---|
|
Rate of Locoregional Control
|
96 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 monthsPopulation: These include all cMO evaluable cases only.
Kaplan-Meier projections.
Outcome measures
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=69 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
Pre-surgery
|
1 Year Post-treatment
|
|---|---|---|---|
|
Freedom From Disease Relapse
|
87 percentage of participants
Interval 76.0 to 98.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Participants who had an ostomy were not included in this outcome measure. Participants who did not complete FACT-C questionnaire at a specific timepoint were not included in that timepoint.
Anorectal function was measured by the participant's response to the FACT-C questionnaire question "I have control of my bowels". The answers ranged from 0=not at all to 4=very much.
Outcome measures
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=72 Participants
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
Pre-surgery
n=59 Participants
|
1 Year Post-treatment
n=31 Participants
|
|---|---|---|---|
|
Determine Quality of Anorectal Function
2 = somewhat
|
22 Participants
|
8 Participants
|
13 Participants
|
|
Determine Quality of Anorectal Function
0 = not at all
|
7 Participants
|
4 Participants
|
2 Participants
|
|
Determine Quality of Anorectal Function
1 = a little bit
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Determine Quality of Anorectal Function
3 = quite a bit
|
14 Participants
|
21 Participants
|
7 Participants
|
|
Determine Quality of Anorectal Function
4 = very much
|
26 Participants
|
22 Participants
|
5 Participants
|
Adverse Events
Neoadjuvant Radiation Followed by FOLFOX
Serious events: 4 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=79 participants at risk
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
|---|---|
|
Investigations
AST
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
2/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Alkaline phosphatase
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Cardiac disorders
Chest pain
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Edema (axilla)
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Fever
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypercholesteremia
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.5%
2/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.5%
2/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.5%
2/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.5%
2/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
INR
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Infections and infestations
Infection with normal ANC
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Leukopenia
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Lymphopenia
|
3.8%
3/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm - bladder
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Renal and urinary disorders
Pain, Dysuria
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Platelets
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Surgical and medical procedures
Port-A-Cath Pain
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Rigors/chills
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Nervous system disorders
Sensory neuropathy
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
Other adverse events
| Measure |
Neoadjuvant Radiation Followed by FOLFOX
n=79 participants at risk
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough (acute)
|
22.8%
18/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough (late)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Creatinine (acute)
|
16.5%
13/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Creatinine (late)
|
16.5%
13/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
ALT, SGPT (acute)
|
43.0%
34/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
ALT, SGPT (late)
|
30.4%
24/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
AST, SGOT (acute)
|
44.3%
35/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
AST, SGOT (late)
|
38.0%
30/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Abdominal pain (acute)
|
24.1%
19/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Abdominal pain (late)
|
36.7%
29/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Alkaline phosphatase (acute)
|
27.8%
22/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Alkaline phosphatase (late)
|
41.8%
33/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (late)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Anal incontinence (acute)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Anal incontinence (late)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Anorexia (acute)
|
45.6%
36/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Anorexia (late)
|
22.8%
18/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain (acute)
|
19.0%
15/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Renal and urinary disorders
Bladder pain (acute)
|
13.9%
11/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain (acute)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Cardiac disorders
Chest pain (acute)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Constipation (acute)
|
48.1%
38/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Constipation (late)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Dehydration (acute)
|
11.4%
9/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Dehydration (late)
|
10.1%
8/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Diarrhea (acute)
|
70.9%
56/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Diarrhea (late)
|
46.8%
37/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Nervous system disorders
Dizziness (acute)
|
32.9%
26/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Nervous system disorders
Dizziness (late)
|
10.1%
8/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin (acute)
|
8.9%
7/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (acute)
|
20.3%
16/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (late)
|
13.9%
11/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Edema: limb (acute)
|
13.9%
11/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Edema: limb (late)
|
8.9%
7/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Reproductive system and breast disorders
Erectile dysfunction (late)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Fatigue (acute)
|
81.0%
64/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Fatigue (late)
|
59.5%
47/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Fever (acute)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Fever (late)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Fistula, GI (late)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Flatulence (acute)
|
12.7%
10/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
GI Leak (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (acute)
|
17.7%
14/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Nervous system disorders
Headache (acute)
|
17.7%
14/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Nervous system disorders
Headache (late)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia (acute)
|
29.1%
23/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin (acute)
|
94.9%
75/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin (late)
|
81.0%
64/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Hemorrhage, GI, Rectum (acute)
|
19.0%
15/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Hemorrhage, GI: melena (acute)
|
11.4%
9/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Vascular disorders
Hot flashes/flushes (acute)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Hyperbilirubinemia (acute)
|
11.4%
9/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Hyperbilirubinemia (late)
|
10.1%
8/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia (acute)
|
43.0%
34/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia (late)
|
30.4%
24/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia (acute)
|
10.1%
8/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia (late)
|
13.9%
11/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia (acute)
|
59.5%
47/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia (late)
|
57.0%
45/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia (acute)
|
83.5%
66/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia (late)
|
45.6%
36/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycemia (acute)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia (acute)
|
30.4%
24/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia (late)
|
29.1%
23/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia (acute)
|
21.5%
17/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia (late)
|
19.0%
15/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia (acute)
|
51.9%
41/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia (late)
|
41.8%
33/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia (acute)
|
16.5%
13/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
INR (acute)
|
26.6%
21/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
INR (late)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Ileus, GI (acute)
|
11.4%
9/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Ileus, GI (late)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Infections and infestations
Infection - UTI (acute)
|
11.4%
9/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (acute)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1/2 neutrophils: abdomen (acute)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1/2 neutrophils: skin (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Psychiatric disorders
Insomnia (acute)
|
32.9%
26/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Psychiatric disorders
Insomnia (late)
|
8.9%
7/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain (acute)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint pain (acute)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Leak, GI (acute)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Leg pain (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Leukopenia (acute)
|
74.7%
59/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Leukopenia (late)
|
67.1%
53/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Lymphopenia (acute)
|
89.9%
71/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Lymphopenia (late)
|
74.7%
59/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Psychiatric disorders
Mood alteration - anxiety (acute)
|
34.2%
27/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Psychiatric disorders
Mood alteration - depression (acute)
|
19.0%
15/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Psychiatric disorders
Mood alteration-anxiety (late)
|
8.9%
7/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Psychiatric disorders
Mood alteration-depression (late)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (acute)
|
8.9%
7/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (acute)
|
19.0%
15/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (late)
|
10.1%
8/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain (acute)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (late)
|
8.9%
7/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Nausea (acute)
|
64.6%
51/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Nausea (late)
|
57.0%
45/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Nervous system disorders
Neuropathy-sensory (late)
|
64.6%
51/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Nervous system disorders
Neuropathy: sensory (acute)
|
87.3%
69/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Neutrophils/granulocytes (acute)
|
46.8%
37/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Neutrophils/granulocytes (late)
|
38.0%
30/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed (acute)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
PTT (acute)
|
20.3%
16/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Renal and urinary disorders
Pain: Dysuria (acute)
|
11.4%
9/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Perianal skin pain (acute)
|
8.9%
7/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Platelets (acute)
|
57.0%
45/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Investigations
Platelets (late)
|
58.2%
46/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching (acute)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation (acute)
|
20.3%
16/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation (acute)
|
12.7%
10/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction (acute)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Rectal pain (acute)
|
34.2%
27/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Rigors/chills (acute)
|
13.9%
11/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Rigors/chills (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Small bowel NOS obstruction (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
General disorders
Sweating (acute)
|
12.7%
10/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Taste alteration (acute)
|
13.9%
11/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Taste alteration (late)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Vascular disorders
Thrombosis/thrombus/embolism (acute)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Urgency, GI (acute)
|
6.3%
5/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Renal and urinary disorders
Urinary frequency/urgency (acute)
|
10.1%
8/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Renal and urinary disorders
Urinary frequency/urgency (late)
|
5.1%
4/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Renal and urinary disorders
Urinary retention (acute)
|
10.1%
8/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Renal and urinary disorders
Urinary retention (late)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Vomiting (acute)
|
30.4%
24/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Vomiting (late)
|
21.5%
17/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Weight loss (acute)
|
12.7%
10/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Gastrointestinal disorders
Weight loss (late)
|
17.7%
14/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious (acute)
|
15.2%
12/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious (late)
|
7.6%
6/79
Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
|
Additional Information
Parag Parikh, M.D.
Washington University School of Medicine
Phone: 314-362-9703
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place