Trial Outcomes & Findings for Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer (NCT NCT00252564)
NCT ID: NCT00252564
Last Updated: 2019-02-15
Results Overview
From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring). Kaplan-Meier median PFS time and PFS rate (at 12 months)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
247 participants
Primary outcome timeframe
12 months
Results posted on
2019-02-15
Participant Flow
A total of 247 patients were recruited from multiple research sites and were randomly assigned to either Arm A or Arm B between December 2005 to June 2007.
The patients were required to be in screening for up to 3 weeks prior to registering the patient for randomization
Participant milestones
| Measure |
Arm A
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
|
Arm B
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
123
|
|
Overall Study
COMPLETED
|
85
|
79
|
|
Overall Study
NOT COMPLETED
|
39
|
44
|
Reasons for withdrawal
| Measure |
Arm A
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
|
Arm B
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
|
|---|---|---|
|
Overall Study
Adverse Event
|
17
|
13
|
|
Overall Study
Unrelated Complication
|
2
|
1
|
|
Overall Study
Disease Progression
|
14
|
20
|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Patient Request
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=124 Participants
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
|
Arm B
n=123 Participants
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 12 • n=5 Participants
|
63 years
STANDARD_DEVIATION 11 • n=7 Participants
|
62 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
124 participants
n=5 Participants
|
123 participants
n=7 Participants
|
247 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient's treatment status.
From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring). Kaplan-Meier median PFS time and PFS rate (at 12 months)
Outcome measures
| Measure |
Arm A
n=124 Participants
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
|
Arm B
n=123 Participants
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
11.0 months
Interval 9.2 to 13.6
|
8.3 months
Interval 6.7 to 9.7
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: ITT population.
From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).
Outcome measures
| Measure |
Arm A
n=124 Participants
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
|
Arm B
n=123 Participants
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
|
|---|---|---|
|
Progression-free Survival (PFS) Rate at 1 Year.
|
0.45 proportion of participants w/ PFS at 1yr
Interval 0.34 to 0.55
|
0.32 proportion of participants w/ PFS at 1yr
Interval 0.23 to 0.42
|
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: ITT population.
From randomization to death (event); or last follow-up date if alive (censoring). Kaplan-Meier OS median time.
Outcome measures
| Measure |
Arm A
n=124 Participants
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
|
Arm B
n=123 Participants
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
|
|---|---|---|
|
Overall Survival (OS)
|
21.3 Months
Interval 18.2 to 25.2
|
19.5 Months
Interval 16.5 to 21.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: This analysis included all eligible and treated patients, i.e. per-protocol population. A patient will be considered in the arm he/she is actually treated, not randomized.
Percentage of patients with tumor response (by RECIST criteria, including complete response, or CR, i.e. disappearance of all target lesions; and partial response, or PR, i.e. at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of the longest diameters) among all "per-protocol population" patients.
Outcome measures
| Measure |
Arm A
n=117 Participants
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
|
Arm B
n=119 Participants
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
|
|---|---|---|
|
Objective Response Rate
|
52.1 percentage of participants
Interval 42.7 to 61.5
|
41.2 percentage of participants
Interval 32.2 to 50.6
|
Adverse Events
Arm A
Serious events: 40 serious events
Other events: 117 other events
Deaths: 0 deaths
Arm B
Serious events: 49 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=118 participants at risk
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
|
Arm B
n=121 participants at risk
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
|
|---|---|---|
|
Immune system disorders
ALLERGIC REACTION
|
0.85%
1/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Immune system disorders
AUTOIMMUNE DEFICIENCY SYNDROME
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.85%
1/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
BRADYCARDIA
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
FIBRILLATION ATRIAL
|
1.7%
2/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
CARDIAC ARREST
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
FAILURE HEART CONGESTIVE
|
1.7%
2/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
HYPERTENSION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
HYPOTENSION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
MYOCARDIAL INFARCT
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
HEALING ABNORMAL
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
HERNIA
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
PYODERMA (SKIN INFECTION)
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Endocrine disorders
KETOSIS
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
2.5%
3/121 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
BOWEL OBSTRUCTION
|
2.5%
3/118 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
BOWEL PERFORATION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
COLON OBSTRUCTION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
COLON ULCER
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DEHYDRATION
|
2.5%
3/118 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
5.8%
7/121 • Number of events 8 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DIARRHEA
|
2.5%
3/118 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
2.5%
3/121 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
FECAL IMPACTION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
GASTROENTERITIS
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
GASTROINTESTINAL PERFORATION (NOS)
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ILEUS
|
0.85%
1/118 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.7%
2/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
3.3%
4/121 • Number of events 4 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
STOMATITIS
|
0.85%
1/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
GASTROINTESTINAL HEMORRHAGE
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.85%
1/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Infections and infestations
FEBRILE NEUTROPENIA
|
2.5%
3/118 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Infections and infestations
INFECTION
|
1.7%
2/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Infections and infestations
SEPSIS
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
3.3%
4/121 • Number of events 4 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.85%
1/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.85%
1/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
FRACTURE BONE
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
DEPRESSION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
HEADACHE
|
0.85%
1/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
MENTAL DETERIORATION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
SYNCOPE
|
0.85%
1/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
PAIN
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
PERITONITIS
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
CHEST PAIN
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
2.5%
3/121 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
1.7%
2/118 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
2.5%
3/121 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.7%
2/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
2.5%
3/121 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLUS
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
2.5%
3/121 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
ACUTE KIDNEY FAILURE
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
ELECTROLYTE ABNORMALITY
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
HYDRONEPHROSIS
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
KIDNEY STONE
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.00%
0/118 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.85%
1/118 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Vascular disorders
THROMBOSIS
|
3.4%
4/118 • Number of events 4 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
5.8%
7/121 • Number of events 9 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
Other adverse events
| Measure |
Arm A
n=118 participants at risk
(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.
Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU
Dosing on Days 1 and 15 of each 28-day cycle
|
Arm B
n=121 participants at risk
(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.
Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
|
|---|---|---|
|
Immune system disorders
ALLERGIC REACTION
|
7.6%
9/118 • Number of events 13 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
3.3%
4/121 • Number of events 4 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Immune system disorders
HYPERSENSITIVITY
|
16.9%
20/118 • Number of events 42 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
ANEMIA
|
38.1%
45/118 • Number of events 93 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
23.1%
28/121 • Number of events 57 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
31.4%
37/118 • Number of events 142 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
21.5%
26/121 • Number of events 124 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
41.5%
49/118 • Number of events 178 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
15.7%
19/121 • Number of events 87 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
35.6%
42/118 • Number of events 160 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
18.2%
22/121 • Number of events 66 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
HYPERTENSION
|
17.8%
21/118 • Number of events 32 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
12.4%
15/121 • Number of events 41 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Cardiac disorders
HYPOTENSION
|
0.85%
1/118 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
5.8%
7/121 • Number of events 8 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
ASTHENIA
|
11.0%
13/118 • Number of events 19 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
18.2%
22/121 • Number of events 31 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
CHILLS
|
7.6%
9/118 • Number of events 13 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
4.1%
5/121 • Number of events 5 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
FATIGUE
|
46.6%
55/118 • Number of events 115 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
33.1%
40/121 • Number of events 71 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
FEVER
|
12.7%
15/118 • Number of events 18 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
13.2%
16/121 • Number of events 20 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
INSOMNIA
|
13.6%
16/118 • Number of events 19 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
13.2%
16/121 • Number of events 17 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
WEAKNESS GENERALIZED
|
6.8%
8/118 • Number of events 9 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
7.4%
9/121 • Number of events 10 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
WEIGHT LOSS
|
16.1%
19/118 • Number of events 35 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
14.0%
17/121 • Number of events 22 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
ACNE
|
1.7%
2/118 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
28.1%
34/121 • Number of events 79 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
12.7%
15/118 • Number of events 19 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
12.4%
15/121 • Number of events 16 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
2.5%
3/118 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
17.4%
21/121 • Number of events 44 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
HAND-FOOT SYNDROME
|
4.2%
5/118 • Number of events 10 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
7.4%
9/121 • Number of events 21 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
4.2%
5/118 • Number of events 5 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
9.1%
11/121 • Number of events 17 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
4.2%
5/118 • Number of events 6 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
8.3%
10/121 • Number of events 19 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Skin and subcutaneous tissue disorders
RASH
|
14.4%
17/118 • Number of events 26 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
68.6%
83/121 • Number of events 168 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
22.0%
26/118 • Number of events 36 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
19.0%
23/121 • Number of events 25 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
ANOREXIA
|
26.3%
31/118 • Number of events 51 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
24.0%
29/121 • Number of events 33 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.4%
30/118 • Number of events 42 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
29.8%
36/121 • Number of events 44 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DEHYDRATION
|
14.4%
17/118 • Number of events 22 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
6.6%
8/121 • Number of events 8 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DIARRHEA
|
44.9%
53/118 • Number of events 110 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
41.3%
50/121 • Number of events 105 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DYSGEUSIA
|
5.9%
7/118 • Number of events 10 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
4.1%
5/121 • Number of events 5 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
DYSPHAGIA
|
5.9%
7/118 • Number of events 7 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
HEARTBURN
|
6.8%
8/118 • Number of events 9 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
2.5%
3/118 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
6.6%
8/121 • Number of events 10 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
MUCOSITIS NOS
|
11.9%
14/118 • Number of events 22 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
13.2%
16/121 • Number of events 26 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
59/118 • Number of events 94 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
44.6%
54/121 • Number of events 103 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
STOMATITIS
|
5.1%
6/118 • Number of events 7 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
15.7%
19/121 • Number of events 23 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
VOMITING
|
27.1%
32/118 • Number of events 44 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
19.8%
24/121 • Number of events 31 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
EPISTAXIS
|
22.9%
27/118 • Number of events 30 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
14.9%
18/121 • Number of events 22 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Infections and infestations
INFECTION
|
6.8%
8/118 • Number of events 13 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
19.0%
23/121 • Number of events 27 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
EDEMA
|
10.2%
12/118 • Number of events 17 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
7.4%
9/121 • Number of events 18 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
9.3%
11/118 • Number of events 20 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
5.8%
7/121 • Number of events 11 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Blood and lymphatic system disorders
HYPOCALCEMIA
|
5.1%
6/118 • Number of events 8 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
6.8%
8/118 • Number of events 13 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
10.7%
13/121 • Number of events 20 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Gastrointestinal disorders
HYPOMAGNESEMIA
|
8.5%
10/118 • Number of events 16 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
21.5%
26/121 • Number of events 27 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Metabolism and nutrition disorders
PROTEINURIA
|
8.5%
10/118 • Number of events 19 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
4.1%
5/121 • Number of events 5 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.1%
6/118 • Number of events 6 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
1.7%
2/121 • Number of events 2 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.2%
12/118 • Number of events 16 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
9.9%
12/121 • Number of events 16 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
5.9%
7/118 • Number of events 7 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
5.0%
6/121 • Number of events 6 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
5.1%
6/118 • Number of events 6 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
5.0%
6/121 • Number of events 6 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Psychiatric disorders
ANXIETY
|
7.6%
9/118 • Number of events 9 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
5.0%
6/121 • Number of events 6 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Psychiatric disorders
DEPRESSION
|
5.9%
7/118 • Number of events 8 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
5.8%
7/121 • Number of events 7 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
DIZZINESS
|
11.9%
14/118 • Number of events 14 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
4.1%
5/121 • Number of events 7 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
HEADACHE
|
13.6%
16/118 • Number of events 20 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
13.2%
16/121 • Number of events 18 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
NEUROPATHY
|
57.6%
68/118 • Number of events 127 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
11.6%
14/121 • Number of events 25 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
PARESTHESIA
|
5.1%
6/118 • Number of events 13 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.00%
0/121 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Nervous system disorders
TINGLING
|
5.1%
6/118 • Number of events 7 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
0.83%
1/121 • Number of events 1 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
General disorders
PAIN
|
16.9%
20/118 • Number of events 36 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
28.1%
34/121 • Number of events 51 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
CHEST PAIN
|
6.8%
8/118 • Number of events 8 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
9.1%
11/121 • Number of events 14 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
COUGHING
|
16.1%
19/118 • Number of events 22 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
12.4%
15/121 • Number of events 18 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
15.3%
18/118 • Number of events 21 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
14.9%
18/121 • Number of events 19 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
INFECTION RESPIRATORY
|
5.1%
6/118 • Number of events 6 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
5.0%
6/121 • Number of events 6 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
5.9%
7/118 • Number of events 7 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
4.1%
5/121 • Number of events 7 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
5.1%
6/118 • Number of events 6 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
2.5%
3/121 • Number of events 3 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Respiratory, thoracic and mediastinal disorders
URINARY TRACT INFECTION
|
5.1%
6/118 • Number of events 10 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
8.3%
10/121 • Number of events 14 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
|
Vascular disorders
THROMBOSIS
|
5.9%
7/118 • Number of events 8 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
8.3%
10/121 • Number of events 10 • during the whole treatment period, up to 30 days following last dose
for treated patients only, assessed at each treatment visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place