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Trial Outcomes & Findings for Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy (NCT NCT00499369)

NCT ID: NCT00499369

Last Updated: 2014-07-31

Results Overview

PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

72 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2014-07-31

Participant Flow

Participant milestones

Participant milestones
Measure
Cohort I: Chemotherapy + Cetuximab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Cetuximab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Bevacizumab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Overall Study
STARTED
16
18
17
9
12
Overall Study
Eligible
14
16
16
8
12
Overall Study
COMPLETED
0
0
0
0
0
Overall Study
NOT COMPLETED
16
18
17
9
12

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort I: Chemotherapy + Cetuximab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Cetuximab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Bevacizumab
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Overall Study
Adverse Event
2
2
3
1
2
Overall Study
Withdrawal by Subject
0
1
1
0
0
Overall Study
Progression
10
12
9
6
10
Overall Study
Death
0
1
0
0
0
Overall Study
Not protocol specified
2
0
3
1
0
Overall Study
Ineligible
2
2
1
1
0

Baseline Characteristics

Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort I: Chemotherapy + Cetuximab
n=14 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab
n=16 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab
n=16 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Cetuximab
n=8 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Bevacizumab
n=12 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Total
n=66 Participants
Total of all reporting groups
Age, Continuous
60 years
n=5 Participants
63 years
n=7 Participants
58 years
n=5 Participants
65 years
n=4 Participants
59 years
n=21 Participants
60 years
n=8 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
8 Participants
n=7 Participants
5 Participants
n=5 Participants
2 Participants
n=4 Participants
7 Participants
n=21 Participants
28 Participants
n=8 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
8 Participants
n=7 Participants
11 Participants
n=5 Participants
6 Participants
n=4 Participants
5 Participants
n=21 Participants
38 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
3 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
11 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=5 Participants
13 Participants
n=7 Participants
12 Participants
n=5 Participants
6 Participants
n=4 Participants
9 Participants
n=21 Participants
52 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
3 Participants
n=8 Participants
Race (NIH/OMB)
White
11 Participants
n=5 Participants
12 Participants
n=7 Participants
12 Participants
n=5 Participants
7 Participants
n=4 Participants
11 Participants
n=21 Participants
53 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
8 Participants
n=8 Participants
Performance Status
0
9 participants
n=5 Participants
8 participants
n=7 Participants
8 participants
n=5 Participants
1 participants
n=4 Participants
4 participants
n=21 Participants
30 participants
n=8 Participants
Performance Status
>= 1
5 participants
n=5 Participants
8 participants
n=7 Participants
8 participants
n=5 Participants
7 participants
n=4 Participants
8 participants
n=21 Participants
36 participants
n=8 Participants
Discontinuation of oxaliplatin while on first-line treatment
Discontinued
5 participants
n=5 Participants
9 participants
n=7 Participants
8 participants
n=5 Participants
4 participants
n=4 Participants
9 participants
n=21 Participants
35 participants
n=8 Participants
Discontinuation of oxaliplatin while on first-line treatment
Did not discontinue
9 participants
n=5 Participants
7 participants
n=7 Participants
8 participants
n=5 Participants
4 participants
n=4 Participants
3 participants
n=21 Participants
31 participants
n=8 Participants
Planned concurrent chemotherapy
FOLFIRI
10 participants
n=5 Participants
11 participants
n=7 Participants
12 participants
n=5 Participants
5 participants
n=4 Participants
8 participants
n=21 Participants
46 participants
n=8 Participants
Planned concurrent chemotherapy
Single-agent irinotecan
4 participants
n=5 Participants
5 participants
n=7 Participants
4 participants
n=5 Participants
3 participants
n=4 Participants
4 participants
n=21 Participants
20 participants
n=8 Participants
Time from last dose of bevacizumab
14-42 days
12 participants
n=5 Participants
13 participants
n=7 Participants
13 participants
n=5 Participants
6 participants
n=4 Participants
8 participants
n=21 Participants
52 participants
n=8 Participants
Time from last dose of bevacizumab
43 days or higher
2 participants
n=5 Participants
3 participants
n=7 Participants
3 participants
n=5 Participants
2 participants
n=4 Participants
4 participants
n=21 Participants
14 participants
n=8 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: All eligible patients are included in this analysis.

PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

Outcome measures

Outcome measures
Measure
Cohort I: Chemotherapy + Cetuximab
n=14 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab
n=16 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab
n=16 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Cetuximab
n=8 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Bevacizumab
n=12 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Progression-free Survival (PFS)
3.2 months
Interval 1.4 to 3.8
4.2 months
Interval 2.2 to 6.7
8.5 months
Interval 2.2 to 9.4
1.4 months
Interval 1.2 to 4.4
5.6 months
Interval 3.4 to 6.9

SECONDARY outcome

Timeframe: Up to 5 years

Population: No participants were analyzed due to limited accrual.

Time to death is from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No participants were analyzed due to limited accrual.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure
Cohort I: Chemotherapy + Cetuximab
n=14 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab
n=16 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab
n=16 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Cetuximab
n=7 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Bevacizumab
n=12 Participants
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Toxicity
Albumin, serum-low (hypoalbuminemia)
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Alkaline phosphatase
0 Participants
0 Participants
1 Participants
1 Participants
0 Participants
Toxicity
Anorexia
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Bilirubin (hyperbilirubinemia)
1 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Colitis, infectious (e.g., Clostridium difficile)
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Confusion
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Constipation
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Cough
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Dehydration
2 Participants
0 Participants
2 Participants
0 Participants
1 Participants
Toxicity
Diarrhea
3 Participants
2 Participants
3 Participants
3 Participants
5 Participants
Toxicity
Dyspnea (shortness of breath)
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Edema: limb
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Edema: trunk/genital
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Encephalopathy
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Fatigue (asthenia, lethargy, malaise)
0 Participants
1 Participants
3 Participants
0 Participants
2 Participants
Toxicity
Febrile neutropenia
2 Participants
2 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Hemoglobin
1 Participants
1 Participants
0 Participants
1 Participants
1 Participants
Toxicity
Hemorrhage, GI - Stoma
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Hypertension
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - Mucosa
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Leukocytes (total WBC)
5 Participants
4 Participants
2 Participants
2 Participants
0 Participants
Toxicity
Lymphopenia
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Magnesium, serum-low (hypomagnesemia)
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Mental status
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Mucositis/stomatitis (clinical exam) - Oral cavity
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Mucositis/stomatitis (functional/symp) - Oral cav
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Mucositis/stomatitis (functional/symp) - Pharynx
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Nasal cavity/paranasal sinus reactions
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Nausea
0 Participants
1 Participants
3 Participants
0 Participants
0 Participants
Toxicity
Neuropathy: sensory
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Toxicity
Neutrophils/granulocytes (ANC/AGC)
4 Participants
7 Participants
7 Participants
3 Participants
3 Participants
Toxicity
Pain - Pain NOS
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Phosphate, serum-low (hypophosphatemia)
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Toxicity
Platelets
1 Participants
2 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Pneumonitis/pulmonary infiltrates
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Toxicity
Potassium, serum-low (hypokalemia)
0 Participants
2 Participants
0 Participants
1 Participants
0 Participants
Toxicity
Rash/desquamation
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Rash: acne/acneiform
3 Participants
2 Participants
4 Participants
2 Participants
0 Participants
Toxicity
Rash: hand-foot skin reaction
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Toxicity
Sodium, serum-low (hyponatremia)
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Toxicity
Thrombosis/thrombus/embolism
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Toxicity
Vomiting
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants

Adverse Events

Cohort I: Chemotherapy + Cetuximab

Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths

Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab

Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths

Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab

Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths

Cohort II: Chemotherapy + Cetuximab

Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths

Cohort II: Chemotherapy + Bevacizumab

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cohort I: Chemotherapy + Cetuximab
n=14 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab
n=16 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab
n=16 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Cetuximab
n=7 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Bevacizumab
n=12 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Blood and lymphatic system disorders
Febrile neutropenia
7.1%
1/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Diarrhea
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
12.5%
2/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Obstruction, GI - Ileum
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Pain - Abdomen NOS
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
General disorders
Fatigue (asthenia, lethargy, malaise)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Infection-Other (Specify)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Investigations
Leukocytes (total WBC)
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Investigations
Neutrophils/granulocytes (ANC/AGC)
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Metabolism and nutrition disorders
Dehydration
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
7.1%
1/14 • Up to 5 years
31.2%
5/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Renal and urinary disorders
Obstruction, GU - Bladder
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Vascular disorders
Hypotension
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years

Other adverse events

Other adverse events
Measure
Cohort I: Chemotherapy + Cetuximab
n=14 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab
n=16 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab
n=16 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Cetuximab
n=7 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Bevacizumab
n=12 participants at risk
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
28.6%
4/14 • Up to 5 years
25.0%
4/16 • Up to 5 years
31.2%
5/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
58.3%
7/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Nail changes
21.4%
3/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Pain - Skin
0.00%
0/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage into skin or mucosa)
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Photosensitivity
7.1%
1/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Pruritus/itching
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Rash/desquamation
14.3%
2/14 • Up to 5 years
18.8%
3/16 • Up to 5 years
37.5%
6/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
71.4%
10/14 • Up to 5 years
81.2%
13/16 • Up to 5 years
81.2%
13/16 • Up to 5 years
85.7%
6/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
0.00%
0/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Vascular disorders
Hemorrhage/Bleeding-Other (Specify)
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Vascular disorders
Hot flashes/flushes
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Vascular disorders
Hypertension
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
25.0%
3/12 • Up to 5 years
Vascular disorders
Thrombosis/thrombus/embolism
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Hemorrhoids
7.1%
1/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Incontinence, anal
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Dry skin
21.4%
3/14 • Up to 5 years
43.8%
7/16 • Up to 5 years
25.0%
4/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
21.4%
3/14 • Up to 5 years
37.5%
6/16 • Up to 5 years
43.8%
7/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
21.4%
3/14 • Up to 5 years
18.8%
3/16 • Up to 5 years
50.0%
8/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
33.3%
4/12 • Up to 5 years
Gastrointestinal disorders
Nausea
57.1%
8/14 • Up to 5 years
37.5%
6/16 • Up to 5 years
81.2%
13/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
75.0%
9/12 • Up to 5 years
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Pain - Abdomen NOS
21.4%
3/14 • Up to 5 years
37.5%
6/16 • Up to 5 years
50.0%
8/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
50.0%
6/12 • Up to 5 years
Gastrointestinal disorders
Pain - Anus
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Gastrointestinal disorders
Pain - Rectum
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Gastrointestinal disorders
Vomiting
28.6%
4/14 • Up to 5 years
43.8%
7/16 • Up to 5 years
50.0%
8/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
66.7%
8/12 • Up to 5 years
General disorders
Constitutional Symptoms-Other (Specify)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
General disorders
Edema: limb
28.6%
4/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
General disorders
Edema: trunk/genital
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
General disorders
Fatigue (asthenia, lethargy, malaise)
57.1%
8/14 • Up to 5 years
62.5%
10/16 • Up to 5 years
81.2%
13/16 • Up to 5 years
85.7%
6/7 • Up to 5 years
83.3%
10/12 • Up to 5 years
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
14.3%
2/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
General disorders
Flu-like syndrome
7.1%
1/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
General disorders
Injection site reaction/extravasation changes
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
General disorders
Pain - Chest/thorax NOS
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
General disorders
Pain - Pain NOS
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
General disorders
Pain-Other (Specify)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
General disorders
Rigors/chills
14.3%
2/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Hepatobiliary disorders
Pain - Liver
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Immune system disorders
Allergic reaction/hypersensitivity
7.1%
1/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Mucosa
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Muscle
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Pharynx
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Ungual
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Infection with unknown ANC - Conjunctiva
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Infection with unknown ANC - Upper airway NOS
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Infections and infestations
Infection-Other (Specify)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Injury, poisoning and procedural complications
Hemorrhage, GI - Stoma
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
14.3%
2/14 • Up to 5 years
18.8%
3/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Investigations
AST, SGOT
14.3%
2/14 • Up to 5 years
37.5%
6/16 • Up to 5 years
43.8%
7/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
58.3%
7/12 • Up to 5 years
Investigations
Alkaline phosphatase
42.9%
6/14 • Up to 5 years
50.0%
8/16 • Up to 5 years
37.5%
6/16 • Up to 5 years
57.1%
4/7 • Up to 5 years
58.3%
7/12 • Up to 5 years
Investigations
Bilirubin (hyperbilirubinemia)
21.4%
3/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
25.0%
3/12 • Up to 5 years
Investigations
Creatinine
14.3%
2/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
33.3%
4/12 • Up to 5 years
Investigations
INR (of prothrombin time)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Investigations
Leukocytes (total WBC)
71.4%
10/14 • Up to 5 years
56.2%
9/16 • Up to 5 years
56.2%
9/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
58.3%
7/12 • Up to 5 years
Investigations
Lymphopenia
7.1%
1/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Investigations
Metabolic/Laboratory-Other (Specify)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
25.0%
3/12 • Up to 5 years
Investigations
Neutrophils/granulocytes (ANC/AGC)
57.1%
8/14 • Up to 5 years
50.0%
8/16 • Up to 5 years
75.0%
12/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
58.3%
7/12 • Up to 5 years
Investigations
Platelets
14.3%
2/14 • Up to 5 years
31.2%
5/16 • Up to 5 years
25.0%
4/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
50.0%
6/12 • Up to 5 years
Investigations
Weight loss
7.1%
1/14 • Up to 5 years
18.8%
3/16 • Up to 5 years
31.2%
5/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
25.0%
3/12 • Up to 5 years
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
28.6%
4/14 • Up to 5 years
50.0%
8/16 • Up to 5 years
25.0%
4/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
50.0%
6/12 • Up to 5 years
Metabolism and nutrition disorders
Anorexia
21.4%
3/14 • Up to 5 years
25.0%
4/16 • Up to 5 years
50.0%
8/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
66.7%
8/12 • Up to 5 years
Metabolism and nutrition disorders
Bicarbonate, serum-low
7.1%
1/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
28.6%
4/14 • Up to 5 years
25.0%
4/16 • Up to 5 years
31.2%
5/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
50.0%
6/12 • Up to 5 years
Metabolism and nutrition disorders
Dehydration
21.4%
3/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
41.7%
5/12 • Up to 5 years
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
35.7%
5/14 • Up to 5 years
25.0%
4/16 • Up to 5 years
50.0%
8/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
66.7%
8/12 • Up to 5 years
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
42.9%
6/14 • Up to 5 years
37.5%
6/16 • Up to 5 years
56.2%
9/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
41.7%
5/12 • Up to 5 years
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
7.1%
1/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
7.1%
1/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
21.4%
3/14 • Up to 5 years
37.5%
6/16 • Up to 5 years
37.5%
6/16 • Up to 5 years
57.1%
4/7 • Up to 5 years
41.7%
5/12 • Up to 5 years
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
7.1%
1/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
14.3%
2/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
58.3%
7/12 • Up to 5 years
Musculoskeletal and connective tissue disorders
Joint-function
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Musculoskeletal and connective tissue disorders
Pain - Back
7.1%
1/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Musculoskeletal and connective tissue disorders
Pain - Joint
0.00%
0/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Musculoskeletal and connective tissue disorders
Pain - Muscle
7.1%
1/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
41.7%
5/12 • Up to 5 years
Nervous system disorders
Ataxia (incoordination)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Nervous system disorders
Cognitive disturbance
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Nervous system disorders
Dizziness
0.00%
0/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
25.0%
3/12 • Up to 5 years
Nervous system disorders
Encephalopathy
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Nervous system disorders
Mental status
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Nervous system disorders
Neuropathy: motor
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Nervous system disorders
Neuropathy: sensory
14.3%
2/14 • Up to 5 years
43.8%
7/16 • Up to 5 years
31.2%
5/16 • Up to 5 years
57.1%
4/7 • Up to 5 years
50.0%
6/12 • Up to 5 years
Nervous system disorders
Ocular/Visual-Other (Specify)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Nervous system disorders
Pain - Head/headache
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Nervous system disorders
Pain - Neuralgia/peripheral nerve
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Nervous system disorders
Taste alteration (dysgeusia)
7.1%
1/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Psychiatric disorders
Confusion
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Psychiatric disorders
Insomnia
14.3%
2/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
25.0%
3/12 • Up to 5 years
Psychiatric disorders
Mood alteration - anxiety
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Psychiatric disorders
Mood alteration - depression
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
12.5%
2/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Renal and urinary disorders
Pain - Bladder
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Renal and urinary disorders
Proteinuria
7.1%
1/14 • Up to 5 years
31.2%
5/16 • Up to 5 years
25.0%
4/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
41.7%
5/12 • Up to 5 years
Renal and urinary disorders
Urinary frequency/urgency
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Renal and urinary disorders
Urine color change
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Reproductive system and breast disorders
Hemorrhage, GU - Vagina
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Cough
7.1%
1/14 • Up to 5 years
25.0%
4/16 • Up to 5 years
25.0%
4/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
0.00%
0/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
7.1%
1/14 • Up to 5 years
31.2%
5/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
41.7%
5/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Mucositis/stomatitis (functional/symp) - Pharynx
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
25.0%
3/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
12.5%
2/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Blood and lymphatic system disorders
Blood/Bone Marrow-Other (Specify)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Blood and lymphatic system disorders
Febrile neutropenia
7.1%
1/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Blood and lymphatic system disorders
Hemoglobin
78.6%
11/14 • Up to 5 years
43.8%
7/16 • Up to 5 years
56.2%
9/16 • Up to 5 years
85.7%
6/7 • Up to 5 years
83.3%
10/12 • Up to 5 years
Cardiac disorders
Pericardial effusion (non-malignant)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Cardiac disorders
SVT and nodal arrhythmia - SVT arrhythmia NOS
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Cardiac disorders
SVT and nodal arrhythmia - Sinus bradycardia
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Cardiac disorders
Ventricular arrhythmia - Ventricular tachycardia
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Ear and labyrinth disorders
Auditory/Ear-Other (Specify)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Ear and labyrinth disorders
Pain - External ear
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Eye disorders
Dry eye syndrome
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Eye disorders
Ocular/Visual-Other (Specify)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Eye disorders
Ophthalmoplegia/diplopia (double vision)
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Eye disorders
Vision-blurred vision
7.1%
1/14 • Up to 5 years
12.5%
2/16 • Up to 5 years
12.5%
2/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Eye disorders
Watery eye (epiphora, tearing)
7.1%
1/14 • Up to 5 years
18.8%
3/16 • Up to 5 years
12.5%
2/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Constipation
35.7%
5/14 • Up to 5 years
25.0%
4/16 • Up to 5 years
56.2%
9/16 • Up to 5 years
85.7%
6/7 • Up to 5 years
33.3%
4/12 • Up to 5 years
Gastrointestinal disorders
Diarrhea
57.1%
8/14 • Up to 5 years
81.2%
13/16 • Up to 5 years
68.8%
11/16 • Up to 5 years
42.9%
3/7 • Up to 5 years
83.3%
10/12 • Up to 5 years
Gastrointestinal disorders
Distention/bloating, abdominal
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
16.7%
2/12 • Up to 5 years
Gastrointestinal disorders
Fistula, GI - Abdomen NOS
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Gastrointestinal disorders
Heartburn/dyspepsia
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
18.8%
3/16 • Up to 5 years
28.6%
2/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Gastrointestinal disorders
Hemorrhage, GI - Lower GI NOS
7.1%
1/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Hemorrhage, GI - Oral cavity
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
14.3%
1/7 • Up to 5 years
8.3%
1/12 • Up to 5 years
Gastrointestinal disorders
Hemorrhage, GI - Rectum
0.00%
0/14 • Up to 5 years
6.2%
1/16 • Up to 5 years
6.2%
1/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
0.00%
0/12 • Up to 5 years
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
0.00%
0/14 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/16 • Up to 5 years
0.00%
0/7 • Up to 5 years
8.3%
1/12 • Up to 5 years

Additional Information

Study Statistician

SWOG

Phone: 206-667-4623

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60