Trial Outcomes & Findings for Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer (NCT NCT00265850)
NCT ID: NCT00265850
Last Updated: 2020-05-07
Results Overview
Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2334 participants
Primary outcome timeframe
Up to 5 years post-treatment
Results posted on
2020-05-07
Participant Flow
From 5/2005 to 9/2009, patients were randomized 1:1:1 to Arms A, B and C. Study was amended in 2009 to include only KRAS wild type patients; then Arm C was closed based on data showing no benefit from chemo with the combination of Bevacizumab and an EGFR antibody. Thereafter, only KRAS wild type patients were randomized 1:1 to Arm A and B.
Participant milestones
| Measure |
Arm A: FOLFOX or FOLFIRI + Bevacizumab
Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm B: FOLFOX or FOLFIRI + Cetuximab
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
899
|
902
|
533
|
|
Overall Study
COMPLETED
|
899
|
902
|
533
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Total
n=1137 Participants
Total of all reporting groups
|
Arm A: FOLFOX or FOLFIRI + Bevacizumab
n=559 Participants
Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm B: FOLFOX or FOLFIRI + Cetuximab
n=578 Participants
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
|---|---|---|---|---|
|
Age, Continuous
|
59.1 years
n=7 Participants
|
59 years
n=99 Participants
|
59.2 years
n=107 Participants
|
—
|
|
Sex: Female, Male
Female
|
440 Participants
n=7 Participants
|
211 Participants
n=99 Participants
|
229 Participants
n=107 Participants
|
—
|
|
Sex: Female, Male
Male
|
697 Participants
n=7 Participants
|
348 Participants
n=99 Participants
|
349 Participants
n=107 Participants
|
—
|
|
Region of Enrollment
Canada
|
64 participants
n=7 Participants
|
32 participants
n=99 Participants
|
32 participants
n=107 Participants
|
—
|
|
Region of Enrollment
United States
|
1073 participants
n=7 Participants
|
527 participants
n=99 Participants
|
546 participants
n=107 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 5 years post-treatmentPopulation: All eligible KRAS wild type patients that began treatment were included in this endpoint.
Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.
Outcome measures
| Measure |
Arm A: FOLFOX or FOLFIRI + Bevacizumab
n=559 Participants
Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm B: FOLFOX or FOLFIRI + Cetuximab
n=578 Participants
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
|---|---|---|---|
|
Overall Survival
|
29.0 months
Interval 25.6 to 31.2
|
30.0 months
Interval 27.5 to 32.8
|
—
|
SECONDARY outcome
Timeframe: Up to 5 years post-treatmentPopulation: All eligible KRAS wild type patients were included in this analysis.
PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.
Outcome measures
| Measure |
Arm A: FOLFOX or FOLFIRI + Bevacizumab
n=559 Participants
Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm B: FOLFOX or FOLFIRI + Cetuximab
n=578 Participants
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
10.6 months
Interval 9.5 to 11.1
|
10.5 months
Interval 9.5 to 11.3
|
—
|
SECONDARY outcome
Timeframe: Up to 5 years post-treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-treatmentOutcome measures
Outcome data not reported
Adverse Events
Arm A: FOLFOX or FOLFIRI + Bevacizumab
Serious events: 98 serious events
Other events: 531 other events
Deaths: 0 deaths
Arm B: FOLFOX or FOLFIRI + Cetuximab
Serious events: 111 serious events
Other events: 548 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: FOLFOX or FOLFIRI + Bevacizumab
n=559 participants at risk
Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm B: FOLFOX or FOLFIRI + Cetuximab
n=578 participants at risk
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Left ventricular failure
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Myocardial ischemia
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Eye disorder
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Ascites
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Esophagitis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Death NOS
|
0.89%
5/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Disease progression
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Fatigue
|
0.72%
4/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Sudden death
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Immune system disorders
Hypersensitivity
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Ileal infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Blood bilirubin increased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Cardiac troponin I increased
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Creatinine increased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Leukocyte count decreased
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Neutrophil count decreased
|
6.3%
35/559 • Number of events 38
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
6.2%
36/578 • Number of events 43
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Platelet count decreased
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Serum cholesterol increased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 12
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Seizure
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Confusion
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Proteinuria
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Thrombosis
|
2.5%
14/559 • Number of events 14
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.8%
22/578 • Number of events 39
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
Other adverse events
| Measure |
Arm A: FOLFOX or FOLFIRI + Bevacizumab
n=559 participants at risk
Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
Arm B: FOLFOX or FOLFIRI + Cetuximab
n=578 participants at risk
Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.89%
5/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.7%
10/578 • Number of events 10
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
17.0%
95/559 • Number of events 161
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
14.4%
83/578 • Number of events 145
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.3%
7/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Atrial tachycardia
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Cardiac disorder
|
0.89%
5/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Cardiac pain
|
0.72%
4/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Left ventricular failure
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Myocardial ischemia
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Myocarditis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Palpitations
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Pericarditis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Cardiac disorders
Ventricular trigeminy
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Ear and labyrinth disorders
Ear pain
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Ear and labyrinth disorders
Hearing test abnormal
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.72%
4/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Endocrine disorders
Hyperthyroidism
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Cataract
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Conjunctivitis
|
0.54%
3/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.1%
12/578 • Number of events 23
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Diplopia
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Dry eye syndrome
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Eye disorder
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Eye pain
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Glaucoma
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Keratitis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Retinopathy
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Vision blurred
|
0.54%
3/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 10
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Eye disorders
Watering eyes
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.72%
4/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.8%
189/559 • Number of events 377
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
32.2%
186/578 • Number of events 327
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Anal exam abnormal
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Anal fistula
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Anal pain
|
0.54%
3/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Ascites
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Cheilitis
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.36%
2/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.89%
5/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.0%
6/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
7.3%
41/559 • Number of events 57
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
10.0%
58/578 • Number of events 91
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
54.4%
304/559 • Number of events 751
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
59.9%
346/578 • Number of events 804
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 10
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Duodenal fistula
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.1%
23/559 • Number of events 27
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.3%
19/578 • Number of events 57
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
9/559 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.0%
6/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
3.8%
21/559 • Number of events 28
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
9.3%
54/578 • Number of events 71
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Endoscopy small intestine abnormal
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Enteritis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Esophagitis
|
0.54%
3/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
6/559 • Number of events 11
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.9%
11/578 • Number of events 12
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.72%
4/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.0%
6/578 • Number of events 25
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.1%
6/559 • Number of events 11
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.4%
8/578 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Gingival pain
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.1%
12/559 • Number of events 18
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.2%
13/578 • Number of events 16
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Ileus
|
1.1%
6/559 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Intestinal necrosis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.9%
44/559 • Number of events 57
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
10.2%
59/578 • Number of events 102
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
16.1%
90/559 • Number of events 114
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
17.3%
100/578 • Number of events 154
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.18%
1/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Peritoneal hemorrhage
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Proctitis
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.89%
5/559 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Rectal mucositis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Rectal pain
|
2.7%
15/559 • Number of events 27
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 12
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.36%
2/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Small intestinal necrosis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
7/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.72%
4/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
31.1%
174/559 • Number of events 284
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
32.0%
185/578 • Number of events 265
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Chest pain
|
2.0%
11/559 • Number of events 15
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Chills
|
7.7%
43/559 • Number of events 51
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
10.7%
62/578 • Number of events 88
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Edema limbs
|
1.3%
7/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.6%
9/578 • Number of events 15
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Facial pain
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Fatigue
|
71.0%
397/559 • Number of events 1213
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
72.3%
418/578 • Number of events 1315
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Fever
|
13.4%
75/559 • Number of events 101
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
11.6%
67/578 • Number of events 83
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Gait abnormal
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
General symptom
|
1.1%
6/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Injection site reaction
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Localized edema
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Pain
|
5.0%
28/559 • Number of events 39
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
5.2%
30/578 • Number of events 32
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
General disorders
Pericardial pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Immune system disorders
Cytokine release syndrome
|
3.9%
22/559 • Number of events 29
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
9.7%
56/578 • Number of events 61
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Immune system disorders
Hypersensitivity
|
2.3%
13/559 • Number of events 14
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.6%
15/578 • Number of events 20
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Abdominal infection
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Anal infection
|
0.18%
1/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Anorectal infection
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Bladder infection
|
1.8%
10/559 • Number of events 14
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Bone infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Bronchitis
|
0.72%
4/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Catheter related infection
|
2.5%
14/559 • Number of events 17
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.7%
10/578 • Number of events 10
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Conjunctivitis infective
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.0%
6/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Device related infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Eye infection
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Gingival infection
|
0.89%
5/559 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Infection
|
2.9%
16/559 • Number of events 19
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.9%
17/578 • Number of events 22
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Infection without neutropenia
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Infectious colitis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Infectious meningitis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Joint infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Kidney infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Laryngitis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Lip infection
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Mediastinal infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Nail infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.8%
16/578 • Number of events 30
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Opportunistic infection
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Otitis media
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Paranasal sinus infection
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Pelvic infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Penile infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Peripheral nerve infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Peritoneal infection
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Pharyngitis
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Pneumonia
|
1.3%
7/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.4%
8/578 • Number of events 10
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Rhinitis infective
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Salivary gland infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Scrotal infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Sepsis
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Sinusitis
|
1.3%
7/559 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Skin infection
|
0.89%
5/559 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.3%
19/578 • Number of events 24
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Small intestine infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Soft tissue infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Tooth infection
|
1.4%
8/559 • Number of events 11
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
1.8%
10/559 • Number of events 16
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Urethral infection
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
24/559 • Number of events 27
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.3%
19/578 • Number of events 21
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Vaginal infection
|
0.54%
3/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Wound infection
|
0.72%
4/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.0%
6/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Infections and infestations
Wound-infectious
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.5%
14/559 • Number of events 24
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.6%
21/578 • Number of events 33
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.89%
5/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
16/559 • Number of events 29
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
4.0%
23/578 • Number of events 38
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Alkaline phosphatase
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
5.7%
32/559 • Number of events 49
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
6.1%
35/578 • Number of events 58
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Amylase increased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
11/559 • Number of events 15
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.6%
21/578 • Number of events 34
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Blood bilirubin increased
|
8.1%
45/559 • Number of events 84
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
9.9%
57/578 • Number of events 108
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Blood gonadotrophin abnormal
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Coagulopathy
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Creatinine increased
|
3.8%
21/559 • Number of events 25
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
INR increased
|
1.8%
10/559 • Number of events 14
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.1%
18/578 • Number of events 40
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Laboratory test abnormal
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Leukocyte count decreased
|
14.1%
79/559 • Number of events 144
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
17.0%
98/578 • Number of events 150
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Lipase increased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
5.2%
29/559 • Number of events 68
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
5.4%
31/578 • Number of events 60
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Neutrophil count decreased
|
56.5%
316/559 • Number of events 716
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
57.8%
334/578 • Number of events 792
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Platelet count decreased
|
37.2%
208/559 • Number of events 541
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
36.3%
210/578 • Number of events 575
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Serum cholesterol increased
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 11
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Weight gain
|
1.8%
10/559 • Number of events 30
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.6%
9/578 • Number of events 21
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Investigations
Weight loss
|
6.3%
35/559 • Number of events 49
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
10.9%
63/578 • Number of events 113
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.7%
71/559 • Number of events 92
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
17.3%
100/578 • Number of events 142
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
13.4%
75/559 • Number of events 141
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
13.8%
80/578 • Number of events 161
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
53/559 • Number of events 62
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
9.2%
53/578 • Number of events 66
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
11.4%
64/559 • Number of events 87
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
10.7%
62/578 • Number of events 90
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
4.5%
25/559 • Number of events 26
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
6.2%
36/578 • Number of events 51
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.89%
5/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
10.0%
56/559 • Number of events 97
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
40.0%
231/578 • Number of events 685
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
1.8%
10/559 • Number of events 14
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
4.3%
25/578 • Number of events 35
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
5.2%
29/559 • Number of events 37
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
9.7%
56/578 • Number of events 72
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.72%
4/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.7%
10/578 • Number of events 11
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
2.9%
16/559 • Number of events 24
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.7%
10/578 • Number of events 11
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
27/559 • Number of events 56
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.4%
14/578 • Number of events 18
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
29/559 • Number of events 56
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
5.0%
29/578 • Number of events 45
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.1%
6/559 • Number of events 12
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.6%
9/578 • Number of events 13
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.72%
4/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.6%
15/578 • Number of events 17
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.72%
4/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
10/559 • Number of events 12
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.9%
11/578 • Number of events 17
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.89%
5/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
20/559 • Number of events 36
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.6%
21/578 • Number of events 28
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis upper limb
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Upper extremity dysfunction
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Ataxia
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 10
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Cognitive disturbance
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.72%
4/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Dizziness
|
3.4%
19/559 • Number of events 25
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
4.8%
28/578 • Number of events 31
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Dysgeusia
|
4.3%
24/559 • Number of events 37
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
5.7%
33/578 • Number of events 47
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 11
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Headache
|
17.5%
98/559 • Number of events 209
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
13.8%
80/578 • Number of events 165
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Memory impairment
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Neuralgia
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Neurological disorder NOS
|
0.89%
5/559 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.6%
9/559 • Number of events 33
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.1%
12/578 • Number of events 20
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
63.5%
355/559 • Number of events 1131
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
59.5%
344/578 • Number of events 1176
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Seizure
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Speech disorder
|
0.89%
5/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Syncope
|
1.8%
10/559 • Number of events 10
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.9%
17/578 • Number of events 19
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Syncope vasovagal
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Tremor
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Agitation
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Anxiety
|
3.9%
22/559 • Number of events 47
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
2.1%
12/578 • Number of events 18
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Confusion
|
1.1%
6/559 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Depression
|
2.9%
16/559 • Number of events 19
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
4.0%
23/578 • Number of events 36
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Insomnia
|
4.7%
26/559 • Number of events 34
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
6.2%
36/578 • Number of events 65
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Libido decreased
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Kidney pain
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Kidney perforation
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Proteinuria
|
28.4%
159/559 • Number of events 335
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
7.4%
43/578 • Number of events 62
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Renal failure
|
1.3%
7/559 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Renal hemorrhage
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Ureteric hemorrhage
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
1.1%
6/559 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
0.89%
5/559 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Renal and urinary disorders
Urogenital disorder
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.18%
1/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Reproductive system and breast disorders
Vaginal mucositis
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.6%
9/559 • Number of events 16
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.18%
1/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
17/559 • Number of events 21
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.9%
11/578 • Number of events 29
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
33/559 • Number of events 53
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
6.4%
37/578 • Number of events 61
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.18%
1/559 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
18/559 • Number of events 29
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.6%
9/559 • Number of events 12
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.72%
4/559 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.4%
8/578 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.89%
5/559 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.6%
9/578 • Number of events 9
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheoscopy abnormal
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.72%
4/559 • Number of events 12
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
16/559 • Number of events 35
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.1%
18/578 • Number of events 27
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Body odor
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.1%
6/559 • Number of events 12
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
6.6%
38/578 • Number of events 74
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.9%
11/578 • Number of events 18
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
4.3%
24/559 • Number of events 53
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
8.0%
46/578 • Number of events 71
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.1%
6/559 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
3.5%
20/578 • Number of events 40
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 7
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.54%
3/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
4.0%
23/578 • Number of events 27
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.6%
9/559 • Number of events 15
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
21.3%
123/578 • Number of events 271
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.3%
13/559 • Number of events 16
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
11.4%
66/578 • Number of events 110
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.89%
5/559 • Number of events 6
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
5.4%
31/578 • Number of events 53
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.1%
6/559 • Number of events 15
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.0%
6/578 • Number of events 16
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/559
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.54%
3/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.87%
5/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.6%
9/559 • Number of events 12
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
1.2%
7/578 • Number of events 21
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.54%
3/559 • Number of events 4
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Flushing
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.17%
1/578 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Hot flashes
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.69%
4/578 • Number of events 8
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Hypertension
|
32.0%
179/559 • Number of events 402
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
13.8%
80/578 • Number of events 184
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Hypotension
|
4.1%
23/559 • Number of events 25
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
6.1%
35/578 • Number of events 40
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Lymph leakage
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Lymphedema
|
0.18%
1/559 • Number of events 1
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.00%
0/578
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Phlebitis
|
0.36%
2/559 • Number of events 3
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.35%
2/578 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Thrombosis
|
7.9%
44/559 • Number of events 97
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
8.7%
50/578 • Number of events 95
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
|
Vascular disorders
Vascular disorder
|
0.36%
2/559 • Number of events 2
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
0.52%
3/578 • Number of events 5
Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60