Trial Outcomes & Findings for A Study in Head and Neck Cancer (NCT NCT01081041)
NCT ID: NCT01081041
Last Updated: 2019-09-25
Results Overview
September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
Part 2: Baseline to end of combination therapy (up to 18 weeks)
Results posted on
2019-09-25
Participant Flow
Two-part study: Part 1 (single arm, safety lead-in) then Part 2 (parallel treatment comparison). All participants to complete 6 cycles of combination therapy then, if eligible, monotherapy. Participant flow presents those who completed study (died); those who were alive or death status unknown at data cut-off considered to not have completed study.
Participant milestones
| Measure |
Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)
Combination Therapy (maximum 6 cycles):
* United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m\^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cisplatin (cis) 100 mg/m\^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-Fluorouracil (5-FU): 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
81
|
73
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
33
|
77
|
71
|
|
Overall Study
COMPLETED
|
33
|
77
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)
n=33 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU
n=77 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU
n=71 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 10.47 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
22 participants
n=5 Participants
|
68 participants
n=7 Participants
|
55 participants
n=5 Participants
|
145 participants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
16 participants
n=7 Participants
|
9 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
2 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
29 participants
n=5 Participants
|
53 participants
n=7 Participants
|
56 participants
n=5 Participants
|
138 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
28 participants
n=5 Participants
|
80 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=5 Participants
|
23 participants
n=7 Participants
|
15 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
29 participants
n=7 Participants
|
27 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Disease Stage at Study Entry
Locoregional
|
6 participants
n=5 Participants
|
34 participants
n=7 Participants
|
32 participants
n=5 Participants
|
72 participants
n=4 Participants
|
|
Disease Stage at Study Entry
Metastatic
|
27 participants
n=5 Participants
|
43 participants
n=7 Participants
|
38 participants
n=5 Participants
|
108 participants
n=4 Participants
|
|
Disease Stage at Study Entry
Unknown or not reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Karnofsky Performance Status (KPS)
KPS 70
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Karnofsky Performance Status (KPS)
KPS 80
|
19 participants
n=5 Participants
|
28 participants
n=7 Participants
|
22 participants
n=5 Participants
|
69 participants
n=4 Participants
|
|
Karnofsky Performance Status (KPS)
KPS 90
|
5 participants
n=5 Participants
|
32 participants
n=7 Participants
|
31 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Karnofsky Performance Status (KPS)
KPS 100
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
23 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Part 2: Baseline to end of combination therapy (up to 18 weeks)Population: Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized. Data is confounded for 9 participants in BI-manufactured cetuximab treatment arm who switched to US commercial cetuximab.
September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=77 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=71 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013
|
76 participants
|
68 participants
|
—
|
PRIMARY outcome
Timeframe: Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks)Population: Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized.
January 23, 2013 is the date when the first participant in the BI-manufactured cetuximab treatment arm switched to US commercial cetuximab due to changes in the manufacturing process for the BI-manufactured cetuximab necessitating the need to switch participants to US commercial cetuximab. Each participant who switched treatments received at least 2 cycles of BI-manufactured cetuximab before switching. All other components of their treatment regimen remained unchanged. The number of participants who had TEAEs during combination therapy is reported. Using January 23 cut-off, data is un-confounded by lack of BI-manufactured cetuximab. TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-in group available in Reported Adverse Event module which is summary of serious and other non-serious AEs regardless of causality.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=77 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=71 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013
|
75 participants
|
68 participants
|
—
|
SECONDARY outcome
Timeframe: Parts 1 and 2: Randomization to Date of Death from any Cause (Up to 36.3 Months)Population: All participants who received at least on dose of study drug. 4 participants were censored in Safety Lead-In, 17 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).
OS was defined as duration from the date of randomization to the date of death from any cause. For each participant not known to have died as of the 23 October 2014 data cutoff date for the analysis, OS was censored at the date last known to be alive. In addition, any participants on Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=33 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=77 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=71 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Overall Survival (OS)
|
9.13 Months
Interval 6.6 to 10.38
|
9.23 Months
Interval 6.9 to 11.8
|
9.46 Months
Interval 6.87 to 11.43
|
SECONDARY outcome
Timeframe: Parts 1 and 2: Randomization to Progression of Disease or Death from any Cause (Up to 32.7 Months)Population: All participants who received at least one dose of study drug. 7 participants were censored in Safety Lead-In ,12 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).
PFS was defined as duration from the date of randomization to the first date of objective progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had objective PD as of the 23 October 2014 data cutoff date for the analysis, PFS was censored at the date of the participant's last complete tumor assessment prior to that cutoff date. In addition, any participant in Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=33 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=77 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=71 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
4.57 Months
Interval 3.22 to 5.32
|
4.34 Months
Interval 3.52 to 5.78
|
5.59 Months
Interval 4.04 to 6.28
|
SECONDARY outcome
Timeframe: Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)Population: All participants who received at least one dose of study drug.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version \[v\]1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants with a confirmed CR or PR=(number of participants whose best overall response was CR or PR)/(number of participants treated)\*100.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=33 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=77 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=71 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
|
24.2 percentage of participants
Interval 9.6 to 38.9
|
32.5 percentage of participants
Interval 22.0 to 42.9
|
36.6 percentage of participants
Interval 25.4 to 47.8
|
SECONDARY outcome
Timeframe: Day 1, Week 1 of Cycles 3 and 5 (postbaseline samples were collected prior to infusion).Population: Participants who received at least 1 dose of study drug and had evaluable data for antibodies.There was no pre-specified analysis plan for trial to report immunogenicity results separately for each arm,as results were intended to be pooled and combined with other cetuximab trials data.Data was pooled for the three arms for cetuximab in this trial.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=85 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Number of Participants With Anti-Cetuximab Antibodies
|
4 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)Population: All participants who received at least one dose of study drug.
Response was defined using RECIST, v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=33 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=77 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=71 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR)
|
69.7 percentage of participants
Interval 54.0 to 85.4
|
58.4 percentage of participants
Interval 47.4 to 69.4
|
62.0 percentage of participants
Interval 50.7 to 73.3
|
SECONDARY outcome
Timeframe: Part 2: Cycle 1, Day 1: 0 hours [(h); immediately postdose], 1 h, 2 h, and 24 h postdosePopulation: Participants who received at least 1 dose of cetuximab (400 mg/m²) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy..
The Cmax of cetuximab following 400 mg/m² cetuximab dosing during Part 2 of the study is reported. As specified in the protocol, pharmacokinetics (PK) samples were not collected during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=61 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=53 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m² Cetuximab Dosing
|
208 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 10.2
|
208 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 7.8
|
—
|
SECONDARY outcome
Timeframe: Part 2: Weekly from Cycle 1, Week 3 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdosePopulation: Participants who received at least 1 dose of cetuximab (400 mg/m\^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.
A total of 4 samples were collected at various times during combination therapy, from the third dose of 250 mg/m\^2 cetuximab in Cycle 1 (Week 3) through the final dose in Cycle 3 (Week 3) and used to report Cmax of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=44 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=46 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Cmax of Cetuximab at Steady State
|
225 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 17.7
|
199 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 15.3
|
—
|
SECONDARY outcome
Timeframe: Part 2: Weekly from Cycle 1, Day 1 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdosePopulation: Participants who received at least 1 dose of cetuximab (250 mg/m\^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.
A total of 4 samples were collected during combination therapy, from the first dose of 250 mg/m\^2 cetuximab in Cycle 1 (Day 1) through the final dose in Cycle 3 (Week 3) and used to report AUC of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.
Outcome measures
| Measure |
Part 2: Combination Therapy: Cetuximab (US Commercial)
n=61 Participants
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
n=55 Participants
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
Part 2: Combination Therapy: Cetuximab (Manufactured by BI)
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
|
|---|---|---|---|
|
Area Under the Concentration Curve (AUC) of Cetuximab at Steady State
|
21900 micrograms*hours/milliliter (μg*h/mL)
Geometric Coefficient of Variation 31.8
|
18800 micrograms*hours/milliliter (μg*h/mL)
Geometric Coefficient of Variation 25.5
|
—
|
Adverse Events
Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)
Serious events: 20 serious events
Other events: 32 other events
Deaths: 0 deaths
Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU
Serious events: 48 serious events
Other events: 64 other events
Deaths: 0 deaths
Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU
Serious events: 42 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)
n=33 participants at risk
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU
n=77 participants at risk
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU
n=71 participants at risk
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.1%
4/33 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.1%
2/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.1%
2/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.1%
2/33 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.8%
6/77 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
4.2%
3/71 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
1/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
6/33 • Number of events 7
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
3.9%
3/77 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
3.0%
1/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Nausea
|
12.1%
4/33 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
9.1%
7/77 • Number of events 10
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
4/33 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
9.1%
7/77 • Number of events 10
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 7
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Asthenia
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Death
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Fatigue
|
9.1%
3/33 • Number of events 10
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
General physical health deterioration
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Medical device complication
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Mucosal inflammation
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Multi-organ failure
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Pain
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Pyrexia
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Thrombosis in device
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Immune system disorders
Anaphylactic reaction
|
6.1%
2/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
3.9%
3/77 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Immune system disorders
Drug hypersensitivity
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Immune system disorders
Hypersensitivity
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Device related infection
|
6.1%
2/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Oral infection
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Pneumonia
|
9.1%
3/33 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
6.5%
5/77 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Sepsis
|
9.1%
3/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
6.5%
5/77 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Septic shock
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.0%
1/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Blood bilirubin increased
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
International normalised ratio increased
|
3.0%
1/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Neutrophil count decreased
|
6.1%
2/33 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Platelet count decreased
|
6.1%
2/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
White blood cell count decreased
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
2/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.2%
5/33 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
9.1%
7/77 • Number of events 10
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
12.7%
9/71 • Number of events 11
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Fluid intake reduced
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.1%
2/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
4.2%
3/71 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Malnutrition
|
6.1%
2/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Cognitive disorder
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Depressed level of consciousness
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Syncope
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
4.2%
3/71 • Number of events 30
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
3.9%
3/77 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
1/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.6%
2/77 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
1/33 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
4.2%
3/71 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
3.9%
3/77 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Embolism
|
6.1%
2/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.4%
1/71 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Thrombosis
|
3.0%
1/33 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
2.8%
2/71 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
1.3%
1/77 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
Other adverse events
| Measure |
Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)
n=33 participants at risk
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU
n=77 participants at risk
Combination Therapy (maximum 6 cycles):
* US commercial cetuximab, manufactured by ImClone, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU
n=71 participants at risk
Combination Therapy (maximum 6 cycles):
* Cetuximab, manufactured by BI, 400 mg/m\^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m\^2 IV infusion weekly.
* Cis 100 mg/m\^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
* 5-FU: 1000 mg/m\^2 IV infusion on Days 1 through 4 of every 21-day cycle.
Monotherapy Therapy:
Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m\^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
24.2%
8/33 • Number of events 24
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
18.2%
6/33 • Number of events 17
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 25
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
9.9%
7/71 • Number of events 22
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
42.4%
14/33 • Number of events 31
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
22.1%
17/77 • Number of events 69
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
32.4%
23/71 • Number of events 82
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
54.5%
18/33 • Number of events 73
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
39.0%
30/77 • Number of events 237
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
40.8%
29/71 • Number of events 161
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.1%
4/33 • Number of events 10
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
14.1%
10/71 • Number of events 38
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.1%
2/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 11
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
11.3%
8/71 • Number of events 25
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Anaemia
|
54.5%
18/33 • Number of events 86
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
24.7%
19/77 • Number of events 103
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
38.0%
27/71 • Number of events 138
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
8.5%
6/71 • Number of events 17
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
3/33 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 19
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 13
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Neutropenia
|
45.5%
15/33 • Number of events 60
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
22.1%
17/77 • Number of events 30
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
32.4%
23/71 • Number of events 64
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
24.2%
8/33 • Number of events 35
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.8%
6/77 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
14.1%
10/71 • Number of events 39
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 18
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Ear and labyrinth disorders
Ear pain
|
9.1%
3/33 • Number of events 14
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.1%
2/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.8%
6/77 • Number of events 68
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
11.3%
8/71 • Number of events 62
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Eye disorders
Eye pruritus
|
9.1%
3/33 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Eye disorders
Vision blurred
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 13
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
4/33 • Number of events 12
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.8%
6/77 • Number of events 18
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
8.5%
6/71 • Number of events 19
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Constipation
|
27.3%
9/33 • Number of events 31
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
20.8%
16/77 • Number of events 48
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
35.2%
25/71 • Number of events 112
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
45.5%
15/33 • Number of events 39
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
29.9%
23/77 • Number of events 47
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
31.0%
22/71 • Number of events 49
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
2/33 • Number of events 15
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
6.5%
5/77 • Number of events 28
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
11.3%
8/71 • Number of events 25
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
8.5%
6/71 • Number of events 24
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.1%
4/33 • Number of events 28
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
9.1%
7/77 • Number of events 32
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
9.9%
7/71 • Number of events 57
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Glossodynia
|
6.1%
2/33 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Nausea
|
57.6%
19/33 • Number of events 88
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
44.2%
34/77 • Number of events 109
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
46.5%
33/71 • Number of events 102
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
6.5%
5/77 • Number of events 21
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Stomatitis
|
27.3%
9/33 • Number of events 36
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
27.3%
21/77 • Number of events 96
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
31.0%
22/71 • Number of events 114
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Gastrointestinal disorders
Vomiting
|
45.5%
15/33 • Number of events 35
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
22.1%
17/77 • Number of events 44
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
35.2%
25/71 • Number of events 82
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Asthenia
|
6.1%
2/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
10.4%
8/77 • Number of events 49
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 15
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Chest pain
|
6.1%
2/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Chills
|
9.1%
3/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Fatigue
|
48.5%
16/33 • Number of events 91
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
45.5%
35/77 • Number of events 204
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
52.1%
37/71 • Number of events 221
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Mucosal inflammation
|
15.2%
5/33 • Number of events 24
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
15.6%
12/77 • Number of events 41
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
22.5%
16/71 • Number of events 83
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Oedema peripheral
|
9.1%
3/33 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 18
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Pain
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
6.5%
5/77 • Number of events 14
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 12
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
General disorders
Pyrexia
|
15.2%
5/33 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
10.4%
8/77 • Number of events 10
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
11.3%
8/71 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Candida infection
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 10
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Paronychia
|
6.1%
2/33 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
11.7%
9/77 • Number of events 74
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
14.1%
10/71 • Number of events 63
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Skin infection
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 14
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
2/33 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
3/33 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
9.1%
1/11 • Number of events 1
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
2/33 • Number of events 2
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.1%
3/33 • Number of events 14
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Blood creatinine increased
|
21.2%
7/33 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
International normalised ratio increased
|
6.1%
2/33 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Lymphocyte count decreased
|
9.1%
3/33 • Number of events 15
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Neutrophil count decreased
|
18.2%
6/33 • Number of events 22
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
14.3%
11/77 • Number of events 26
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
19.7%
14/71 • Number of events 35
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Platelet count decreased
|
15.2%
5/33 • Number of events 14
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
14.3%
11/77 • Number of events 51
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
14.1%
10/71 • Number of events 48
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
Weight decreased
|
21.2%
7/33 • Number of events 34
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
13.0%
10/77 • Number of events 58
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
19.7%
14/71 • Number of events 65
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Investigations
White blood cell count decreased
|
18.2%
6/33 • Number of events 15
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.2%
6/33 • Number of events 26
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
19.5%
15/77 • Number of events 70
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
29.6%
21/71 • Number of events 69
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
24.2%
8/33 • Number of events 17
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
10.4%
8/77 • Number of events 12
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
16.9%
12/71 • Number of events 23
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
9.1%
3/33 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
3/33 • Number of events 23
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.1%
2/33 • Number of events 4
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.1%
2/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 31
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
3/33 • Number of events 13
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
6.5%
5/77 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 12
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
12.7%
9/71 • Number of events 41
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
6.5%
5/77 • Number of events 13
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 25
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33 • Number of events 16
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
11.7%
9/77 • Number of events 43
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
15.5%
11/71 • Number of events 29
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Dysgeusia
|
18.2%
6/33 • Number of events 30
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 12
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
11.3%
8/71 • Number of events 27
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Headache
|
6.1%
2/33 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
9.1%
7/77 • Number of events 37
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
8.5%
6/71 • Number of events 10
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.1%
2/33 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
8.5%
6/71 • Number of events 19
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
3/33 • Number of events 21
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
9.9%
7/71 • Number of events 55
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Nervous system disorders
Syncope
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Psychiatric disorders
Anxiety
|
6.1%
2/33 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 17
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Psychiatric disorders
Confusional state
|
9.1%
3/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Psychiatric disorders
Depression
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 29
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
8.5%
6/71 • Number of events 24
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Psychiatric disorders
Insomnia
|
9.1%
3/33 • Number of events 28
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
13.0%
10/77 • Number of events 78
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
15.5%
11/71 • Number of events 80
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
3/33 • Number of events 7
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 22
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
12.7%
9/71 • Number of events 39
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.2%
5/33 • Number of events 14
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
13.0%
10/77 • Number of events 90
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
18.3%
13/71 • Number of events 80
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
3/33 • Number of events 7
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.8%
6/77 • Number of events 43
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
8.5%
6/71 • Number of events 21
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.1%
3/33 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
8.5%
6/71 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
2/33 • Number of events 10
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
6.5%
5/77 • Number of events 16
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 14
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.1%
2/33 • Number of events 3
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 17
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
9.9%
7/71 • Number of events 44
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
51.5%
17/33 • Number of events 101
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
33.8%
26/77 • Number of events 254
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
26.8%
19/71 • Number of events 134
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
3/33 • Number of events 17
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
24.7%
19/77 • Number of events 142
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
16.9%
12/71 • Number of events 87
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
9.1%
3/33 • Number of events 11
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
10.4%
8/77 • Number of events 60
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
8.5%
6/71 • Number of events 27
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.2%
5/33 • Number of events 17
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 34
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 22
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.2%
7/33 • Number of events 41
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
14.3%
11/77 • Number of events 91
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
26.8%
19/71 • Number of events 152
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 13
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 31
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
9.1%
3/33 • Number of events 8
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.8%
6/77 • Number of events 48
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
11.3%
8/71 • Number of events 48
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.1%
2/33 • Number of events 6
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
7.0%
5/71 • Number of events 14
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Embolism
|
0.00%
0/33
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.2%
4/77 • Number of events 37
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Hypertension
|
6.1%
2/33 • Number of events 26
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/77
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
0.00%
0/71
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • Number of events 9
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
13.0%
10/77 • Number of events 27
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
5.6%
4/71 • Number of events 5
Serious adverse events (SAEs) and other non-serious AEs are reported for participants who received at least 1 dose of any drug (cetuximab, cisplatin, carboplatin, or 5-FU). Death due to progressive disease was not considered an AE.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60