Trial Outcomes & Findings for Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer (NCT NCT00265941)

NCT ID: NCT00265941

Last Updated: 2022-06-14

Results Overview

Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 940 participants
• Primary outcome timeframe: From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
• Results posted on: 2022-06-14

Participant Flow

Participant milestones

Measure	RT + Cisplatin Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Study STARTED	470	470
Overall Study COMPLETED	447	444
Overall Study NOT COMPLETED	23	26

Reasons for withdrawal

Measure	RT + Cisplatin Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Overall Study Protocol Violation	22	25
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Baseline characteristics by cohort

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Total n=891 Participants Total of all reporting groups
Age, Continuous	57 years n=93 Participants	58 years n=4 Participants	57 years n=27 Participants
Sex: Female, Male Female	60 Participants n=93 Participants	45 Participants n=4 Participants	105 Participants n=27 Participants
Sex: Female, Male Male	387 Participants n=93 Participants	399 Participants n=4 Participants	786 Participants n=27 Participants

PRIMARY outcome

Timeframe: From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)

Population: Randomized eligible patients with follow-up data

Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases.

Outcome measures

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Progression-free Survival (PFS) (3-year Rate Reported)	61.2 percentage of participants Interval 56.7 to 65.8	58.9 percentage of participants Interval 54.2 to 63.6	—	—

SECONDARY outcome

Timeframe: From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)

Population: Randomized eligible patients with follow-up data

Overall survival is defined as time from randomization to date of death from any cause. Patients last known to be alive are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method.

Outcome measures

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Overall Survival (OS) (3-year Rate Reported)	72.9 percentage of participants Interval 68.7 to 77.1	75.8 percentage of participants Interval 71.7 to 79.9	—	—

SECONDARY outcome

Timeframe: From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)

Population: Randomized eligible patients with follow-up data

Local-regional failure is defined as time from randomization to date of failure (local or regional progression), or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Distant disease progression is considered a competing risk. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases. Three-year rates were estimated by the cumulative incidence method.

Outcome measures

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Local-regional Failure (LRF) (3-year Rate Reported)	19.9 percentage of participants Interval 16.2 to 23.7	25.9 percentage of participants Interval 21.7 to 30.1	—	—

SECONDARY outcome

Timeframe: From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)

Population: Randomized eligible patients with follow-up data

Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Outcome measures

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Rate of Mucositis Toxicity ≥ Grade 3	33.3 percentage of participants Interval 29.0 to 37.7	43.2 percentage of participants Interval 38.6 to 47.9	—	—

SECONDARY outcome

Timeframe: From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)

Population: Randomized eligible patients with follow-up data

Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 other than radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Outcome measures

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Rate of Other Toxicity ≥ Grade 3 (Not Mucositis)	89.3 percentage of participants Interval 86.4 to 92.1	91.9 percentage of participants Interval 89.4 to 94.4	—	—

SECONDARY outcome

Timeframe: From start of treatment to end of treatment (6-7 weeks)

Population: Randomized eligible patients with follow-up data

A patient was considered to have tolerated treatment if radiation therapy was scored as per protocol or with acceptable variation, they received 2 cycles of cisplatin, and for arm 2, they received the initial dose of cetuximab and at least 5 weekly doses of cetuximab .

Outcome measures

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Rate of Patients Who Tolerated Treatment	84.8 percentage of participants Interval 81.5 to 88.1	70.7 percentage of participants Interval 66.5 to 75.0	—	—

SECONDARY outcome

Timeframe: From start of treatment to 30 days after the end of treatment

Population: Randomized eligible patients with follow-up data

Patients who died during treatment or within 30 days after the end of treatment

Outcome measures

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Rate of Deaths ≤ 30 Days After Discontinuation of Protocol Treatment	1.8 percentage of participants Interval 0.6 to 3.0	2.0 percentage of participants Interval 0.7 to 3.3	—	—

SECONDARY outcome

Timeframe: 3 months and 12 months

Population: Randomized eligible patients with EQ-5D data at the given time point.

The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state).

Outcome measures

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D) EQ-5D 3 months	0.78 units on a scale Standard Deviation 0.18	0.77 units on a scale Standard Deviation 0.15	—	—
Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D) EQ-5D 12 months	0.84 units on a scale Standard Deviation 0.17	0.84 units on a scale Standard Deviation 0.16	—	—

SECONDARY outcome

Timeframe: 3 months and 12 months

Population: Randomized eligible patients with PSS-HN data at the given time point.

The PSS-HN is a clinician rated instrument consisting of assessment of three functions (subscales): Normalcy of Diet, Eating in Public, and Understandability of Speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores on each subscale range from 0-100, with higher scores indicating better performance. It has been demonstrated to be reliable and valid in head and neck cancer patients.The site research nurse or clinical research associate (CRA) will determine the score on each of the subscales by performing a clinical evaluation and unstructured interview format. The PSS-HN takes approximately 5 minutes to complete.

Outcome measures

Measure	RT + Cisplatin n=447 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50 Normalcy of Diet 3 months	0.80 proportion of participants Interval 0.75 to 0.84	0.85 proportion of participants Interval 0.8 to 0.89	—	—
Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50 Public Eating 3 months	0.62 proportion of participants Interval 0.56 to 0.67	0.63 proportion of participants Interval 0.59 to 0.67	—	—
Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50 Understandability of Speech 3 months	0.09 proportion of participants Interval 0.06 to 0.12	0.08 proportion of participants Interval 0.05 to 0.12	—	—
Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50 Understandability of Speech 12 months	0.05 proportion of participants Interval 0.02 to 0.08	0.04 proportion of participants Interval 0.02 to 0.07	—	—
Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50 Normalcy of Diet 12 months	0.37 proportion of participants Interval 0.31 to 0.43	0.37 proportion of participants Interval 0.31 to 0.44	—	—
Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50 Public Eating 12 months	0.18 proportion of participants Interval 0.13 to 0.23	0.23 proportion of participants Interval 0.18 to 0.28	—	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Randomized eligible patients with baseline and 12-month FACT-HN data.

The Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) is a 10-item self-report instrument designed to measure multidimensional quality of life in patients with head and neck cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-40. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-HN including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Change from baseline to 12 months (12 months - baseline) is reported.

Outcome measures

Measure	RT + Cisplatin n=229 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=226 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months	-0.41 units on a scale Standard Deviation 18.9	-5.11 units on a scale Standard Deviation 22.5	—	—

SECONDARY outcome

Timeframe: From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)

Population: Randomized eligible patients with follow-up and EGFR data.

EGFR expression is categorized as high (>/=80%) and low (<80%) in order to compare outcome by favorable and unfavorable risk group, per protocol. Times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional progression (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.

Outcome measures

Measure	RT + Cisplatin n=235 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=145 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF Progression-free survival (PFS)	63.5 percentage of participants Interval 56.9 to 69.4	60.3 percentage of participants Interval 51.7 to 67.8	—	—
Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF Overall survival (OS)	76.7 percentage of participants Interval 70.6 to 81.7	75.0 percentage of participants Interval 66.9 to 81.4	—	—
Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF Loco-regional failure (LRF)	21.7 percentage of participants Interval 16.6 to 27.3	19.2 percentage of participants Interval 13.1 to 26.1	—	—

SECONDARY outcome

Timeframe: From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)

Population: Randomized eligible N2-3 patients with follow-up and PET data

SUVmax is categorized as high (>median) and low (</=median). All times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional failure (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.

Outcome measures

Measure	RT + Cisplatin n=34 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=34 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET No clinical nodal complete response; positive post-treatment PET/CT scan
Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF Progression-free Survival (PFS)	55.9 percentage of participants Interval 37.8 to 70.6	85.3 percentage of participants Interval 68.2 to 93.6	—	—
Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF Overall Survival (OS)	85.3 percentage of participants Interval 68.2 to 93.6	91.2 percentage of participants Interval 75.1 to 97.1	—	—
Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF Loco-regional failure (LRF)	32.4 percentage of participants Interval 17.4 to 48.3	11.8 percentage of participants Interval 3.6 to 25.1	—	—

SECONDARY outcome

Timeframe: From randomization to 2 years

Population: Randomized eligible N2-3 patients with follow-up and PET data

Patients are grouped by the combination of clinical nodal response status and the post-treatment PET/CT finding (negative or positive). Nodal relapse rate is calculated for each group by the cumulative incidence method. Relapse is defined as reappearance of tumor after complete response. If possible, relapse should be confirmed by biopsy.

Outcome measures

Measure	RT + Cisplatin n=26 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=15 Participants Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab	Clinical CR + Positive PET n=12 Participants Clinical nodal complete response; positive post-treatment PET/CT scan	No Clinical CR + Positive PET n=9 Participants No clinical nodal complete response; positive post-treatment PET/CT scan
2-year Nodal Relapse Rates in Clinical N2-3 Patients by Post-treatment PET/CT Finding and Nodal Response	3.9 percentage of participants Interval 0.0 to 11.4	33.3 percentage of participants Interval 8.4 to 58.3	16.7 percentage of participants Interval 0.0 to 38.8	11.1 percentage of participants Interval 0.0 to 33.1

Adverse Events

RT + Cisplatin

Serious events: 208 serious events

Other events: 442 other events

Deaths: 0 deaths

RT + Cisplatin + Cetuximab

Serious events: 237 serious events

Other events: 433 other events

Deaths: 0 deaths

Serious adverse events

Measure	RT + Cisplatin n=447 participants at risk Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 participants at risk Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Blood and lymphatic system disorders Blood/bone marrow - Other	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Febrile neutropenia	6.9% 31/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.4% 24/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemoglobin	5.4% 24/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.2% 32/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemolysis NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Arrhythmia NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial fibrillation	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial flutter	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Cardiac general - Other	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Cor pulmonale NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Left ventricular failure	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Myocardial ischemia	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.1% 5/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Sinus arrhythmia	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Sinus bradycardia	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Ventricular tachycardia	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Hearing impaired	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Otitis externa NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Pain: External ear	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Tinnitus	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Endocrine disorders Endocrine - Other	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal distention	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain NOS	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.8% 8/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	2.2% 10/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.2% 14/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea NOS	1.6% 7/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.2% 14/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dry mouth	1.1% 5/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 9/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Duodenal perforation	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	11.4% 51/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.4% 46/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Enteritis necroticans	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal pain	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal perforation	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal stenosis acquired	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophagitis NOS	0.89% 4/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.6% 7/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Fistula, GI: Abdomen NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Fistula, GI: Oral cavity	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Fistula, Pulmonary/upper respiratory: Oral cavity	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastric ulcer	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastritis NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal - Other	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Hemorrhage, GI: Upper GI NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Hemorrhoids	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Intra-abdominal hemorrhage NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Malabsorption	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam): Anus	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic): Esophagus	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	8.1% 36/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.3% 59/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Oral pain	3.6% 16/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.1% 18/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Pancreatitis NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Radiation mucositis	6.3% 28/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	11.7% 52/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal perforation	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal ulcer	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Salivary gland disorder NOS	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.1% 5/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Small intestinal stricture NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Stomatitis	0.89% 4/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.1% 5/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Tooth disorder NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting NOS	6.9% 31/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.1% 45/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Chest pain	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Constitutional Symptoms - Other	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Death NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Disease progression NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema: head and neck	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema: limb	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema: trunk/genital	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Facial pain	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	1.8% 8/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.1% 27/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Multi-organ failure	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain - Other	0.89% 4/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pyrexia	2.7% 12/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.3% 28/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Rigors	0.89% 4/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.90% 4/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Sudden death	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Hepatobiliary disorders Gallbladder obstruction	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Hepatobiliary disorders Hepatic failure	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Immune system disorders Cytokine release syndrome	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Immune system disorders Hypersensitivity NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.4% 15/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Abdominal infection	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Ano-rectal infection NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Bladder infection NOS	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Bone infection NOS	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Bronchitis NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Gingival infection	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Implant site infection	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection - Other	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.1% 5/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Abdomen NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bladder (urinary)	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bone (osteomyelitis)	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Brain + Spinal cord (encephalomyelitis)	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Catheter-related	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Dental-tooth	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Esophagus	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Foreign body (e.g., graft, implant, pro	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia)	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Middle ear (otitis media)	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Mucosa	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Nose	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Oral cavity-gums (gingivitis)	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Pancreas	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Stomach	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Trachea	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Wound	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Blood	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.4% 6/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Catheter-related	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Esophagus	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Larynx	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Lip/perioral	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Neck NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Salivary gland	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Wound	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with unknown ANC: Lung (pneumonia)	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with unknown ANC: Trachea	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Nasopharyngitis	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Opportunisitic infection	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.90% 4/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Otitis media NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Peritoneal infection	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Pharyngitis	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Pneumonia NOS	2.5% 11/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.4% 6/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Respiratory tract infection NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Sepsis NOS	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Skin infection	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.6% 7/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Urinary tract infection NOS	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Wound infection	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Burn	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Culture wound negative	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Dermatitis radiation NOS	1.1% 5/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.90% 4/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Hemorrhage, Pulmonary/upper respiratory: Trachea	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Radiation recall syndrome	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.8% 17/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Tracheal stenosis	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Vascular access NOS complication	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Vessel injury-artery: Carotid	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alanine aminotransferase increased	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.4% 6/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Aspartate aminotransferase increased	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.4% 6/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood alkaline phosphatase increased	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood amylase increased	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood bilirubin increased	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.1% 5/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood creatine phosphokinase increased	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood creatinine increased	4.5% 20/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.3% 19/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Coagulopathy	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Gamma-glutamyltransferase increased	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Inappropriate antidiuretic hormone secretion	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Leukopenia NOS	7.6% 34/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.6% 38/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lipase increased	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	2.2% 10/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.9% 26/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Metabolic/laboratory - Other	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count	6.9% 31/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 34/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	1.6% 7/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.9% 13/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Prothrombin time prolonged	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Troponin I increased	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Troponin T increased	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight decreased	4.7% 21/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.1% 18/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	2.7% 12/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.8% 17/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Blood iron increased	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	15.2% 68/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	18.0% 80/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypercalcemia	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia NOS	1.8% 8/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 10/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperkalemia	0.89% 4/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.90% 4/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypermagnesemia	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypernatremia	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperuricemia	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	2.2% 10/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.8% 17/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	1.6% 7/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.6% 16/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoglycemia NOS	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	2.5% 11/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.6% 25/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypomagnesemia	1.1% 5/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.1% 18/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	3.4% 15/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.2% 32/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypophosphatemia	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.4% 6/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Back pain	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness NOS	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Neck pain	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Osteonecrosis	1.6% 7/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Soft tissue necrosis: Head	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Soft tissue necrosis: Neck	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy - possibly related to cancer treatment	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Cerebral ischemia	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Cognitive disorder	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Convulsions NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Depressed level of consciousness	1.3% 6/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dysgeusia	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.90% 4/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Hemorrhagic stroke	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Memory impairment	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Mental status changes	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Neuralgia NOS	1.1% 5/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Neurology - Other	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral motor neuropathy	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Speech disorder	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Syncope	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.90% 4/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Syncope vasovagal	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Agitation	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Anxiety	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Confusional state	1.1% 5/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.6% 7/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Depression	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.90% 4/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Psychosis aggravated	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Bladder obstruction	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Glomerular filtration rate	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Renal failure NOS	3.8% 17/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.7% 12/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Renal/genitourinary - Other	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Aspiration	0.89% 4/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 7/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.1% 5/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.4% 15/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.8% 8/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hemorrhage, Pulmonary/upper respiratory: Bronchopulmonary NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hemorrhage, Pulmonary/upper respiratory: Pharynx	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.89% 4/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.4% 6/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Laryngeal discomfort	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	2.2% 10/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.90% 4/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Laryngeal stensos	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Laryngitis NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam): Larynx	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam): Pharynx	2.5% 11/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.7% 12/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (functional/symptomatic): Larynx	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (functional/symptomatic): Pharynx	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reactions	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Obstruction/stenosis of airway: Pharynx	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pharyngeal fistula	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.7% 12/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.0% 9/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pneumonitis NOS	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.4% 6/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pneumothorax NOS	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory - Other	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Acne NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.5% 11/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 10/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatology/skin - Other	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Nail disorder NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.68% 3/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin atrophy	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin fibrosis	0.67% 3/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Telangiectasia	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Ulceration	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hemorrhage/bleeding - Other	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.45% 2/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypertension NOS	0.00% 0/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.23% 1/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypotension NOS	2.0% 9/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.6% 16/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Peripheral ischemia	0.22% 1/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Thrombosis	0.89% 4/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	1.8% 8/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Vascular - Other	0.45% 2/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Measure	RT + Cisplatin n=447 participants at risk Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin	RT + Cisplatin + Cetuximab n=444 participants at risk Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
Blood and lymphatic system disorders Blood/bone marrow - Other	6.9% 31/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.0% 31/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemoglobin	58.6% 262/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	56.3% 250/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Ear pain	7.8% 35/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.4% 33/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Hearing impaired	28.4% 127/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	25.7% 114/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Tinnitus	26.2% 117/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.9% 106/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Endocrine disorders Hypothyroidism	18.3% 82/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.8% 70/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain NOS	5.6% 25/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.2% 32/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	38.0% 170/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	32.9% 146/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea NOS	17.0% 76/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.7% 92/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dry mouth	78.7% 352/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	77.5% 344/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dyspepsia	11.6% 52/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	11.3% 50/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	96.4% 431/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	93.5% 415/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal stenosis acquired	6.3% 28/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.9% 35/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophagitis NOS	4.3% 19/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.9% 26/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal - Other	12.3% 55/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	11.5% 51/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	56.4% 252/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	54.7% 243/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Oral pain	32.0% 143/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	35.6% 158/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Radiation mucositis	78.1% 349/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	82.0% 364/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Salivary gland disorder NOS	40.0% 179/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	35.8% 159/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Tooth disorder NOS	8.7% 39/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.4% 33/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting NOS	38.0% 170/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	40.3% 179/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema: head and neck	26.6% 119/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	26.4% 117/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema: limb	5.1% 23/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.3% 19/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	72.3% 323/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	71.2% 316/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain - Other	14.3% 64/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.5% 69/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain NOS	6.0% 27/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.3% 28/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pyrexia	12.5% 56/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	16.4% 73/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Rigors	4.0% 18/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 30/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Gingival infection	5.6% 25/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	5.2% 23/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection - Other	4.7% 21/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.6% 38/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Dermatitis radiation NOS	59.1% 264/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	51.6% 229/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Radiation recall syndrome	28.9% 129/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	45.0% 200/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alanine aminotransferase increased	19.0% 85/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	21.6% 96/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Aspartate aminotransferase increased	15.9% 71/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	15.5% 69/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood alkaline phosphatase increased	10.7% 48/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.7% 34/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood bilirubin increased	3.8% 17/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.6% 38/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood creatinine increased	24.2% 108/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	18.2% 81/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Leukopenia NOS	46.3% 207/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	46.4% 206/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	21.9% 98/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	19.6% 87/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Metabolic/laboratory - Other	10.3% 46/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.4% 46/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count	30.0% 134/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	27.9% 124/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	22.4% 100/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	24.3% 108/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight decreased	56.6% 253/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	59.2% 263/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	36.5% 163/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	36.0% 160/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	26.4% 118/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.4% 104/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia NOS	33.3% 149/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	38.3% 170/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperkalemia	8.9% 40/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.4% 46/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypermagnesemia	6.5% 29/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	3.8% 17/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	28.4% 127/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	30.9% 137/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	20.1% 90/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	26.1% 116/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	18.8% 84/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	23.0% 102/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypomagnesemia	23.7% 106/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	34.2% 152/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	36.9% 165/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	41.9% 186/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Back pain	6.3% 28/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.5% 20/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Fibrosis-deep connective tissue	5.1% 23/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.7% 21/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness NOS	5.1% 23/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.0% 31/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue - Other	7.4% 33/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.8% 48/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Neck pain	17.9% 80/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	21.6% 96/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Osteonecrosis	10.3% 46/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.9% 44/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Trismus	21.7% 97/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	22.3% 99/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	9.6% 43/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	12.4% 55/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dysgeusia	54.8% 245/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	54.1% 240/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache	12.5% 56/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	18.7% 83/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Neuralgia NOS	21.0% 94/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	19.6% 87/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral motor neuropathy	4.7% 21/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.5% 29/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	24.6% 110/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	27.3% 121/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Anxiety	14.3% 64/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	10.8% 48/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Depression	14.3% 64/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	14.0% 62/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia	15.2% 68/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	16.2% 72/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Aspiration	6.9% 31/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.3% 28/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	24.6% 110/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	21.2% 94/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.4% 60/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	14.6% 65/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hiccups	5.4% 24/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.5% 20/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Laryngeal discomfort	5.1% 23/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.9% 13/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	46.8% 209/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	45.0% 200/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Laryngitis NOS	39.6% 177/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	34.2% 152/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam): Larynx	19.0% 85/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	16.7% 74/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam): Pharynx	53.7% 240/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	49.1% 218/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	41.4% 185/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	34.7% 154/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory - Other	10.5% 47/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.1% 36/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Acne NOS	2.9% 13/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	65.5% 291/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	21.0% 94/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.3% 90/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	13.0% 58/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	46.4% 206/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dermatology/skin - Other	33.6% 150/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	35.6% 158/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dry skin	5.8% 26/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.1% 36/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Pruritus	7.6% 34/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	34.5% 153/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin fibrosis	49.2% 220/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	48.0% 213/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	21.0% 94/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	19.6% 87/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin hypopigmentation	5.8% 26/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.3% 28/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Telangiectasia	8.3% 37/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	7.2% 32/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypotension NOS	6.9% 31/447 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	8.8% 39/444 Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: seiferheldw@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
• Publication restrictions are in place

Restriction type: OTHER