Trial Outcomes & Findings for Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer (NCT NCT00500760)
NCT ID: NCT00500760
Last Updated: 2018-10-17
Results Overview
In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
2 years
Results posted on
2018-10-17
Participant Flow
153 patients were enrolled with 89 patients on panitumumab plus chemoradiation arm, and 64 patients on chemoradiotherapy alone arm.
Participant milestones
| Measure |
Panitumumab Plus Chemoradiation
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
64
|
|
Overall Study
Received Treatment
|
87
|
63
|
|
Overall Study
COMPLETED
|
46
|
40
|
|
Overall Study
NOT COMPLETED
|
43
|
24
|
Reasons for withdrawal
| Measure |
Panitumumab Plus Chemoradiation
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
|---|---|---|
|
Overall Study
Death
|
32
|
15
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Administrative decision
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Panitumumab Plus Chemoradiation
n=89 Participants
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
n=64 Participants
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
56.6 Years
STANDARD_DEVIATION 8.8 • n=107 Participants
|
57.4 Years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
82 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Radiotherapy delivery modality
IMRT
|
52 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Radiotherapy delivery modality
3D-CRT
|
35 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Radiotherapy delivery modality
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Primary tumor site
Oropharynx/Larynx
|
68 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Primary tumor site
Oral Cavity/Hypopharynx
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Nodal status
N0
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Nodal status
N+
|
77 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Tumor stage
T1-3
|
64 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Tumor stage
T4
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Efficacy Analysis Set (all randomized participants who received at least 1 dose of protocol-specified treatment according to treatment randomization regardless of treatment received.)
In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
Outcome measures
| Measure |
Panitumumab Plus Chemoradiation
n=87 Participants
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
n=63 Participants
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
|---|---|---|
|
Local Regional Control Rate at 2 Years
|
0.61 proportion of paticipants
Interval 0.5 to 0.71
|
0.68 proportion of paticipants
Interval 0.54 to 0.78
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Efficacy Analysis Set
Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
Outcome measures
| Measure |
Panitumumab Plus Chemoradiation
n=87 Participants
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
n=63 Participants
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
|---|---|---|
|
Local Regional Control Rate at 6 Months and 12 Months
6 months
|
0.70 proportion of paticipants
Interval 0.59 to 0.79
|
0.73 proportion of paticipants
Interval 0.6 to 0.83
|
|
Local Regional Control Rate at 6 Months and 12 Months
12 months
|
0.66 proportion of paticipants
Interval 0.55 to 0.75
|
0.70 proportion of paticipants
Interval 0.56 to 0.8
|
SECONDARY outcome
Timeframe: From first dose up to 37 monthsPopulation: Efficacy Analysis Set
Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0.
Outcome measures
| Measure |
Panitumumab Plus Chemoradiation
n=87 Participants
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
n=63 Participants
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
|---|---|---|
|
Duration of Local-regional Control
|
33.7 months
Interval 28.8 to
Upper limit could not be estimated due to the low number of events
|
NA months
Median could not be estimated due to the low number of events.
|
SECONDARY outcome
Timeframe: From first dose date to 37 monthsPopulation: Efficacy Analysis Set
Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death. Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions. Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date.
Outcome measures
| Measure |
Panitumumab Plus Chemoradiation
n=87 Participants
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
n=63 Participants
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
|---|---|---|
|
Progression-Free Survival
|
NA months
Interval 24.3 to
Could not be estimated due to the low number of events
|
NA months
Interval 25.6 to
Could not be estimated due to the low number of events
|
SECONDARY outcome
Timeframe: From first dose date up to 37 monthsPopulation: Efficacy Analysis Set
Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date.
Outcome measures
| Measure |
Panitumumab Plus Chemoradiation
n=87 Participants
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
n=63 Participants
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
|---|---|---|
|
Overall Survival
|
33.7 months
Interval 32.2 to
Could not be estimated due to the low number of events
|
NA months
Interval 34.6 to
Could not be estimated due to the low number of events
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Evaluable for Central Tumor Response Analysis Set: the subset of participants in the Efficacy Analysis Set with at least one bi-dimensionally measurable lesion at baseline using a modified version of the WHO criteria per blinded central review.
Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions.
Outcome measures
| Measure |
Panitumumab Plus Chemoradiation
n=87 Participants
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
n=62 Participants
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
|---|---|---|
|
Percentage of Participants With an Objective Response at 6 Months
|
71.26 percentage of participants
Interval 60.57 to 80.46
|
82.26 percentage of participants
Interval 70.47 to 90.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Evaluable for Central Tumor Response Analysis Set
Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions.
Outcome measures
| Measure |
Panitumumab Plus Chemoradiation
n=87 Participants
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemoradiotherapy Alone
n=62 Participants
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
|
|---|---|---|
|
Percentage of Participants With a Complete Response at 6 Months
|
20.69 percentage of participants
Interval 12.75 to 30.71
|
19.35 percentage of participants
Interval 10.42 to 31.37
|
Adverse Events
Panitumumab Plus Chemoradiation
Serious events: 37 serious events
Other events: 87 other events
Deaths: 0 deaths
Chemotherapy Plus Radiotherapy
Serious events: 20 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panitumumab Plus Chemoradiation
n=87 participants at risk
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemotherapy Plus Radiotherapy
n=63 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
2/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Dysphagia
|
6.9%
6/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
6.3%
4/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Glossitis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
6.9%
6/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
6.3%
4/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Odynophagia
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
3.2%
2/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
6.3%
4/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Asthenia
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Chest pain
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
General physical health deterioration
|
3.4%
3/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Mucosal inflammation
|
6.9%
6/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Pyrexia
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Bacteraemia
|
2.3%
2/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Bronchitis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Candidiasis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Device related infection
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Diverticulitis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Infection
|
2.3%
2/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Pneumonia
|
3.4%
3/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
3.2%
2/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Pneumonia bacterial
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Pulmonary sepsis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Sialoadenitis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Staphylococcal sepsis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Injury, poisoning and procedural complications
Stomatitis radiation
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Investigations
Blood sodium decreased
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Investigations
Weight decreased
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
3.2%
2/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Nervous system disorders
Diabetic ketoacidotic hyperglycaemic coma
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Psychiatric disorders
Confusional state
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Psychiatric disorders
Disorientation
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
4.8%
3/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
3.2%
2/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
2/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Vascular disorders
Circulatory collapse
|
2.3%
2/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Vascular disorders
Haemorrhage
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Vascular disorders
Hypotension
|
1.1%
1/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
Other adverse events
| Measure |
Panitumumab Plus Chemoradiation
n=87 participants at risk
Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
|
Chemotherapy Plus Radiotherapy
n=63 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
21/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
20.6%
13/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.9%
6/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
12.7%
8/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Ear and labyrinth disorders
Deafness
|
4.6%
4/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
11.1%
7/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Ear and labyrinth disorders
Tinnitus
|
9.2%
8/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
19.0%
12/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Constipation
|
39.1%
34/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
33.3%
21/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.7%
18/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
11.1%
7/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Dry mouth
|
47.1%
41/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
52.4%
33/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.8%
12/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
9.5%
6/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Dysphagia
|
63.2%
55/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
63.5%
40/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
51.7%
45/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
57.1%
36/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Odynophagia
|
24.1%
21/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
30.2%
19/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Oral pain
|
10.3%
9/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
4.8%
3/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Stomatitis
|
17.2%
15/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
17.5%
11/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
29/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
33.3%
21/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Asthenia
|
13.8%
12/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
11.1%
7/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Fatigue
|
21.8%
19/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
28.6%
18/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Mucosal inflammation
|
81.6%
71/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
71.4%
45/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Oedema peripheral
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
3.2%
2/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Pain
|
9.2%
8/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
General disorders
Pyrexia
|
11.5%
10/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
11.1%
7/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Candidiasis
|
12.6%
11/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Device related infection
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Infection
|
10.3%
9/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Infections and infestations
Oral candidiasis
|
11.5%
10/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
11.1%
7/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
66.7%
58/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
82.5%
52/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Investigations
Blood creatinine increased
|
6.9%
6/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
7.9%
5/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
7.9%
5/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Investigations
Weight decreased
|
42.5%
37/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
44.4%
28/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.0%
20/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
30.2%
19/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
6/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
14.3%
9/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.5%
10/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
6.3%
4/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.8%
12/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
17.5%
11/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.1%
14/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
9.5%
6/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.0%
7/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
4.8%
3/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.6%
4/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
7.9%
5/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Nervous system disorders
Dizziness
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
11.1%
7/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Nervous system disorders
Dysgeusia
|
24.1%
21/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
42.9%
27/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Nervous system disorders
Headache
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
6.3%
4/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
4.8%
3/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Psychiatric disorders
Anxiety
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
4.8%
3/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Psychiatric disorders
Depression
|
6.9%
6/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Psychiatric disorders
Insomnia
|
14.9%
13/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
19.0%
12/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
7/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
14.3%
9/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
19.5%
17/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
19.0%
12/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.6%
4/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
9.5%
6/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
11.1%
7/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Acne
|
18.4%
16/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.3%
9/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
12.7%
8/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
11.5%
10/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.9%
13/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.6%
11/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.9%
6/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.9%
13/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
46.0%
40/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
1.6%
1/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
5.7%
5/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
0.00%
0/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
|
Vascular disorders
Hypotension
|
8.0%
7/87 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
3.2%
2/63 • The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER