Trial Outcomes & Findings for Trial With Cetuximab in Maintenance Therapy After Platinum Based Chemotherapy in First Line Treatment of Non-small Cell Lung Cancer (NSCLC) (NCT NCT00820755)
NCT ID: NCT00820755
Last Updated: 2014-05-05
Results Overview
The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
583 participants
Primary outcome timeframe
Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)
Results posted on
2014-05-05
Participant Flow
First/last participants (informed consent): January 2009/17 March 2010. Clinical data cut-off: 17 December 2011
Enrolled: 673 screened for eligibility; 90 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 583 participants started.
Participant milestones
| Measure |
Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy
Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m\^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m\^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m\^2 on D1; or gemcitabine 1250 mg/m\^2 on D1 and D8+cisplatin 75 mg/m\^2 on D1; or gemcitabine 1000 mg/m\^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg\*hour/milliliter (mg\*h/mL) on D1; or Docetaxel 75 mg/m\^2 on D1+cisplatin 75 mg/m\^2 on D1; or paclitaxel 175 mg/m\^2 on D1+cisplatin 80 mg/m\^2 on D1; or paclitaxel 200 mg/m\^2 on D1+carboplatin at dose to reach AUC6 mg\*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
|
Cetuximab 500 mg/m^2 Every 2 Weeks
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|
|
Period 1: Combination Therapy Phase
STARTED
|
583
|
0
|
0
|
|
Period 1: Combination Therapy Phase
COMPLETED
|
313
|
0
|
0
|
|
Period 1: Combination Therapy Phase
NOT COMPLETED
|
270
|
0
|
0
|
|
Period 2: Maintenance Therapy Phase
STARTED
|
0
|
157
|
154
|
|
Period 2: Maintenance Therapy Phase
COMPLETED
|
0
|
112
|
109
|
|
Period 2: Maintenance Therapy Phase
NOT COMPLETED
|
0
|
45
|
45
|
Reasons for withdrawal
| Measure |
Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy
Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m\^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m\^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m\^2 on D1; or gemcitabine 1250 mg/m\^2 on D1 and D8+cisplatin 75 mg/m\^2 on D1; or gemcitabine 1000 mg/m\^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg\*hour/milliliter (mg\*h/mL) on D1; or Docetaxel 75 mg/m\^2 on D1+cisplatin 75 mg/m\^2 on D1; or paclitaxel 175 mg/m\^2 on D1+cisplatin 80 mg/m\^2 on D1; or paclitaxel 200 mg/m\^2 on D1+carboplatin at dose to reach AUC6 mg\*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
|
Cetuximab 500 mg/m^2 Every 2 Weeks
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|
|
Period 1: Combination Therapy Phase
Adverse Event
|
77
|
0
|
0
|
|
Period 1: Combination Therapy Phase
Death
|
28
|
0
|
0
|
|
Period 1: Combination Therapy Phase
Protocol Violation
|
4
|
0
|
0
|
|
Period 1: Combination Therapy Phase
Lost to Follow-up
|
1
|
0
|
0
|
|
Period 1: Combination Therapy Phase
Withdrawal by Subject
|
21
|
0
|
0
|
|
Period 1: Combination Therapy Phase
Progressive disease
|
114
|
0
|
0
|
|
Period 1: Combination Therapy Phase
Sympt. deterioration w/o PD by imaging
|
14
|
0
|
0
|
|
Period 1: Combination Therapy Phase
Other
|
11
|
0
|
0
|
|
Period 2: Maintenance Therapy Phase
Investigational study phase ongoing
|
0
|
45
|
45
|
Baseline Characteristics
Trial With Cetuximab in Maintenance Therapy After Platinum Based Chemotherapy in First Line Treatment of Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy
n=583 Participants
Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m\^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m\^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m\^2 on D1; or gemcitabine 1250 mg/m\^2 on D1 and D8+cisplatin 75 mg/m\^2 on D1; or gemcitabine 1000 mg/m\^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg\*hour/milliliter (mg\*h/mL) on D1; or Docetaxel 75 mg/m\^2 on D1+cisplatin 75 mg/m\^2 on D1; or paclitaxel 175 mg/m\^2 on D1+cisplatin 80 mg/m\^2 on D1; or paclitaxel 200 mg/m\^2 on D1+carboplatin at dose to reach AUC6 mg\*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
|
|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 9.28 • n=93 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
436 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)Population: Intention-to-treat (ITT) maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on computer tomography \[CT\] or magnetic resonance imaging \[MRI\] scan) by the Investigator and randomized to maintenance therapy.
The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.
Outcome measures
| Measure |
Cetuximab 500 mg/m^2 Every 2 Weeks
n=157 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
n=154 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Survival (OS) Time
|
16.1 months
Interval 13.6 to 18.2
|
15.5 months
Interval 13.2 to 19.7
|
PRIMARY outcome
Timeframe: Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until one year after the last participant was included (March 2010)Population: ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.
The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier. Percentage of participants who were still alive until one year after the last participant was included (March 2010).
Outcome measures
| Measure |
Cetuximab 500 mg/m^2 Every 2 Weeks
n=157 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
n=154 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants With 1-year Overall Survival
|
62.8 percentage of participants
Interval 54.7 to 70.0
|
64.4 percentage of participants
Interval 56.2 to 71.4
|
SECONDARY outcome
Timeframe: Time from randomization in cetuximab maintenance regimen to death or last day known to be alive, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)Population: ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.
The OS time is defined as the time from randomization in cetuximab maintenance regimen to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.
Outcome measures
| Measure |
Cetuximab 500 mg/m^2 Every 2 Weeks
n=157 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
n=154 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Overall Survival (OS) Time (From Randomization to Cetuximab Maintenance Regimen Until Death)
|
12.6 months
Interval 10.1 to 14.8
|
12.6 months
Interval 9.3 to 16.0
|
SECONDARY outcome
Timeframe: Time from trial inclusion to treatment failure or last drug intake, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)Population: ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.
Time to treatment failure is defined as the time from trial inclusion to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of inclusion (Day 1) if they received no study drug.
Outcome measures
| Measure |
Cetuximab 500 mg/m^2 Every 2 Weeks
n=157 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
n=154 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Time to Treatment Failure
|
5.8 months
Interval 5.6 to 6.6
|
6.6 months
Interval 6.1 to 6.9
|
SECONDARY outcome
Timeframe: Time from randomization in cetuximab maintenance regimen to treatment failure or last drug intake, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)Population: ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.
Time from randomization in cetuximab maintenance regimen to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of randomization (Day 1 of maintenance therapy) if they received no study drug.
Outcome measures
| Measure |
Cetuximab 500 mg/m^2 Every 2 Weeks
n=157 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
n=154 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Time to Treatment Failure (From Randomization to Cetuximab Maintenance Regimen Until Death)
|
2.6 months
Interval 2.1 to 2.8
|
2.8 months
Interval 2.6 to 4.0
|
SECONDARY outcome
Timeframe: Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)Population: ITT analysis set included all participants enrolled in this study.
The response rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the unconfirmed best overall response (BOR) according to centrally reviewed investigator assessments based on an independent review charter (IRC). As per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Cetuximab 500 mg/m^2 Every 2 Weeks
n=583 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants With Best Unconfirmed Tumor Response in the Combination Therapy Phase
|
36.2 percentage of participants
Interval 32.3 to 40.2
|
—
|
SECONDARY outcome
Timeframe: Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)Population: ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.
The response rate is defined as the percentage of participants having achieved CR and PR as the BOR according to IRC assessment in combination therapy phase and radiological assessments (based on response evaluation criteria in solid tumors \[RECIST\] Version 1.0) in the maintenance therapy phase. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Cetuximab 500 mg/m^2 Every 2 Weeks
n=157 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
n=154 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participant With Best Unconfirmed Tumor Response for the Whole Study Period
|
54.8 percentage of participants
Interval 46.6 to 62.7
|
57.8 percentage of participants
Interval 49.6 to 65.7
|
SECONDARY outcome
Timeframe: Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)Population: ITT analysis set included all participants enrolled in this study.
The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed BOR according to IRC assessment.
Outcome measures
| Measure |
Cetuximab 500 mg/m^2 Every 2 Weeks
n=583 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants With Disease Control in the Combination Therapy Phase
|
65.7 percentage of participants
Interval 61.7 to 69.5
|
—
|
SECONDARY outcome
Timeframe: Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)Population: ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.
The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed best overall response according to IRC assessment in combination therapy phase and radiological assessments (based on RECIST Version 1.0 criteria) in the maintenance therapy phase.
Outcome measures
| Measure |
Cetuximab 500 mg/m^2 Every 2 Weeks
n=157 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m\^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
|
Cetuximab 250 mg/m^2 Weekly
n=154 Participants
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|
|
Percentage of Participants With Disease Control for the Whole Study Period
|
98.7 percentage of participants
Interval 95.5 to 99.8
|
99.4 percentage of participants
Interval 96.4 to 100.0
|
Adverse Events
Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy
Serious events: 243 serious events
Other events: 564 other events
Deaths: 0 deaths
Cetuximab 500 mg/m^2 Every 2 Weeks
Serious events: 30 serious events
Other events: 121 other events
Deaths: 0 deaths
Cetuximab 250 mg/m^2 Weekly
Serious events: 33 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy
n=583 participants at risk
Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m\^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m\^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m\^2 on D1; or gemcitabine 1250 mg/m\^2 on D1 and D8+cisplatin 75 mg/m\^2 on D1; or gemcitabine 1000 mg/m\^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg\*hour/milliliter (mg\*h/mL) on D1; or Docetaxel 75 mg/m\^2 on D1+cisplatin 75 mg/m\^2 on D1; or paclitaxel 175 mg/m\^2 on D1+cisplatin 80 mg/m\^2 on D1; or paclitaxel 200 mg/m\^2 on D1+carboplatin at dose to reach AUC6 mg\*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
|
Cetuximab 500 mg/m^2 Every 2 Weeks
n=156 participants at risk
Participants who were free of disease progression after combination therapy, they administered with cetuximab 500 mg/m\^2 intravenously for 2 weeks, for up to PD, development of unacceptable toxicities, or withdrawal of consent after the end of combination therapy.
|
Cetuximab 250 mg/m^2 Weekly
n=155 participants at risk
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
6/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
13/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
8/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Nausea
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
11/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
9/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Constipation
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Stomatitis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Dyspepsia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Asthenia
|
1.4%
8/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Fatigue
|
1.0%
6/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Pyrexia
|
1.5%
9/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Oedema peripheral
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
Platelet count decreased
|
0.86%
5/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
Alanine aminotransferase increased
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
White blood cell count decreased
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
Neutrophil count decreased
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.69%
4/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.86%
5/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Dizziness
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Headache
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
10/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Febdrile bone marrow aplasia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.4%
20/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.5%
32/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.69%
4/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Angina unstable
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Arrhythmia superaventricular
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Cardiac arrest
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Cardiac failure
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Cardiac failure congestive
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Electromechanical dissociation
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Myocardial infarction
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Pericardial effusion
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Pericarditis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Sinus tachycardia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Cardiac disorders
Tachycardia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Congenital, familial and genetic disorders
Aplasia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Abdominal distension
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Dysphagia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Haematemesis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Pancreatitis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Death
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Device leakage
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Disease progression
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
General physical health deterioration
|
0.69%
4/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Infusion related reaction
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Multi-organ failure
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Organ failure
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Pain
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Hepatobiliary disorders
Hepatic failure
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Immune system disorders
Anaphylactic reaction
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Immune system disorders
Anaphylactic shock
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Immune system disorders
Drug hypersensitivity
|
1.4%
8/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Anorectal infection
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Bronchitis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Cellulitis
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Device related infection
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Empyema
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Febrile infection
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Herpes zoster
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Kidney infection
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Lower respiratory tract infection
|
0.86%
5/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Lung infection
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Neutropenic sepsis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Pneumonia
|
2.9%
17/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
2.6%
4/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
2.6%
4/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Pseudomembranous colitis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Pyothorax
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Respiratory tract infection
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Sepsis
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Septic shock
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Skin infection
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Urinary tract infection
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
Blood creatinine increased
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
C-Reactive protein increased
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Dehydration
|
0.69%
4/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Cerebral ischaemia
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Cerebrovascular accident
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Cognitive disorder
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Convulsion
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Depressed level of consciousness
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Ischaemic stroke
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Spinal cord compression
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Syncope
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Transient ischaemic attack
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Psychiatric disorders
Disorientation
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Renal and urinary disorders
Haematuria
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Renal and urinary disorders
Renal failure
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Renal and urinary disorders
Renal failure acute
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
6/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.86%
5/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
12/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Aortic thrombosis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Deep vein thrombosis
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Femoral artery embolism
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Hypotension
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Peripheral ischaemia
|
0.51%
3/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Thrombophlebitis
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Eye disorders
Diplopia
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Endocarditis
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.64%
1/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Immune system disorders
Hypersensitivity
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Subcutaneous abscess
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.69%
4/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.86%
5/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.17%
1/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.65%
1/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Hypertension
|
0.34%
2/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
Other adverse events
| Measure |
Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy
n=583 participants at risk
Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m\^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m\^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m\^2 on D1; or gemcitabine 1250 mg/m\^2 on D1 and D8+cisplatin 75 mg/m\^2 on D1; or gemcitabine 1000 mg/m\^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg\*hour/milliliter (mg\*h/mL) on D1; or Docetaxel 75 mg/m\^2 on D1+cisplatin 75 mg/m\^2 on D1; or paclitaxel 175 mg/m\^2 on D1+cisplatin 80 mg/m\^2 on D1; or paclitaxel 200 mg/m\^2 on D1+carboplatin at dose to reach AUC6 mg\*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
|
Cetuximab 500 mg/m^2 Every 2 Weeks
n=156 participants at risk
Participants who were free of disease progression after combination therapy, they administered with cetuximab 500 mg/m\^2 intravenously for 2 weeks, for up to PD, development of unacceptable toxicities, or withdrawal of consent after the end of combination therapy.
|
Cetuximab 250 mg/m^2 Weekly
n=155 participants at risk
Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m\^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.0%
134/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.8%
9/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
9.7%
15/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.3%
72/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.7%
208/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.2%
112/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
13/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
21/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
31/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Constipation
|
18.7%
109/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.9%
3/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
7.7%
12/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Diarrhoea
|
20.6%
120/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
3.8%
6/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
9.7%
15/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
36/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Nausea
|
36.4%
212/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.9%
3/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.8%
9/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Odynophagia
|
0.86%
5/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Stomatitis
|
8.1%
47/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Gastrointestinal disorders
Vomiting
|
20.9%
122/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.2%
8/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Asthenia
|
21.3%
124/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
3.8%
6/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
10.3%
16/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Chills
|
2.7%
16/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Fatigue
|
19.6%
114/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
4.5%
7/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
8.4%
13/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Influenza like illness
|
1.9%
11/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Mucosal Inflammation
|
11.5%
67/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Non-cardiac chest pain
|
3.9%
23/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.1%
8/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
4.5%
7/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Oedema peripheral
|
3.6%
21/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
General disorders
Pyrexia
|
11.8%
69/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.8%
9/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
6.5%
10/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Paronychia
|
5.1%
30/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.8%
9/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
7.7%
12/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
24/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
26/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
Haemoglobin decreased
|
6.9%
40/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
Neutrophil count decreased
|
3.3%
19/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
Platelet count decreased
|
6.9%
40/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Investigations
White blood cell count decreased
|
3.4%
20/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.2%
112/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.1%
8/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
8.4%
13/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.3%
37/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.8%
69/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.8%
9/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
9.0%
14/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.4%
14/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
33/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
3.2%
5/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
7.1%
11/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
30/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
3.8%
6/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.2%
8/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.86%
5/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
26/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
31/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Dizziness
|
6.0%
35/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
2.6%
4/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.2%
8/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Dysgeusia
|
4.8%
28/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Headache
|
5.0%
29/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
4.5%
7/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.8%
9/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Neuropathy peripheral
|
4.5%
26/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.4%
8/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.5%
38/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.8%
9/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
3.9%
6/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Psychiatric disorders
Insomnia
|
5.3%
31/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
69/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
9.0%
14/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
9.0%
14/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.4%
49/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
43/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
12.8%
20/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
14.2%
22/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.9%
17/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.6%
15/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.2%
13/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Rash
|
52.5%
306/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
25.6%
40/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
25.8%
40/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.7%
109/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.2%
83/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
7.1%
11/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
10.3%
16/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
51/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
6.4%
10/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
3.9%
6/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.9%
46/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.8%
9/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
7.1%
11/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.3%
31/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.0%
6/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Hypertension
|
3.3%
19/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Vascular disorders
Phlebitis
|
2.2%
13/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
0.00%
0/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
4.5%
7/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
6.5%
10/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
6.4%
10/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
3.9%
6/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
1.3%
2/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
5.2%
8/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/583 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
7.1%
11/156 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
8.4%
13/155 • Time from Baseline up to 30 days after the last dose of study treatment.
One participant who was randomized to 'Cetuximab 500 mg/m\^2 Every 2 Weeks' arm actually received 'Cetuximab 250 mg/m\^2 Weekly' treatment and was counted in this group for safety analysis
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER