Trial Outcomes & Findings for Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck (NCT NCT00720304)

NCT ID: NCT00720304

Last Updated: 2024-08-22

Results Overview

Percent of participants with Disease-Free survival (DFS) at 3 years. Assessed from date of treatment to date of death or date of disease progression, and to date of last follow-up for those still alive and progression free. Disease-free Survival percentages were calculated using Kaplan-Meier estimates.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: 3 yrs after treatment
• Results posted on: 2024-08-22

Participant Flow

Participant milestones

Measure	CASE5307 - Oral Erlotinib Hydrochloride Weekly docetaxel (20 mg/m2), EGF-R inhibition: Erlotinib 150 mg/day (prior to, during and up to two years following XRT)	Participants From CWRU1301 Participants from CWRU1301 - NCT00049283 who received Docetaxel 20 mg/m2/wk Erlotinib 150 mg/day XRT
Overall Study STARTED	37	6
Overall Study COMPLETED	8	1
Overall Study NOT COMPLETED	29	5

Reasons for withdrawal

Measure	CASE5307 - Oral Erlotinib Hydrochloride Weekly docetaxel (20 mg/m2), EGF-R inhibition: Erlotinib 150 mg/day (prior to, during and up to two years following XRT)	Participants From CWRU1301 Participants from CWRU1301 - NCT00049283 who received Docetaxel 20 mg/m2/wk Erlotinib 150 mg/day XRT
Overall Study Withdrawal by Subject	14	1
Overall Study Death	1	0
Overall Study Physician Decision	5	2
Overall Study Adverse Event	3	1
Overall Study Disease progression	6	1

Baseline Characteristics

Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck

Baseline characteristics by cohort

Measure	CASE5307 - Oral Erlotinib Hydrochloride n=37 Participants Docetaxel, erlotinib hydrochloride, fluorescence in situ hybridization, polymerase chain reaction, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, therapeutic conventional surgery, intensity-modulated radiation therapy, radiation therapy	Participants From CWRU1301 n=6 Participants Participants from CWRU1301 - NCT00049283 who received Docetaxel 20 mg/m2/wk Erlotinib 150 mg/day XRT	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	6 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	0 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	5 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	5 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	3 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	6 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 yrs after treatment

Population: Participants enrolled in study

Percent of participants with Disease-Free survival (DFS) at 3 years. Assessed from date of treatment to date of death or date of disease progression, and to date of last follow-up for those still alive and progression free. Disease-free Survival percentages were calculated using Kaplan-Meier estimates.

Outcome measures

Measure	Oral Erlotinib Hydrochloride n=43 Participants docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Neutropenia Neutropenia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anemia Anemia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Oral Mucositis Oral mucositis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Radiation Dermatitis Radiation dermatitis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Acneiform Skin Rash Acneiform skin rash Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dysphagia Dysphagia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anorexia Anorexia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Nausia/Vomiting Nausia/vomiting Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dehydration Dehydration Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
Percent of Participants With Disease-Free Survival (DFS) at 3 Years	69.5 Percent	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 3 yrs after treatment

Population: Data not available because response data not collected

Time from start of treatment to first documented occurrence of progressive disease (PD). PD defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 yrs after treatment

Population: Data not available because response data not collected

Response rate according to response criteria, which defines the following:

Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: Participants enrolled in study

Percent of participants alive at follow-up time. Overall survival time is evaluated from the date of treatment to date of death, and to date of last follow-up for those still alive.

Outcome measures

Measure	Oral Erlotinib Hydrochloride n=43 Participants docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Neutropenia Neutropenia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anemia Anemia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Oral Mucositis Oral mucositis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Radiation Dermatitis Radiation dermatitis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Acneiform Skin Rash Acneiform skin rash Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dysphagia Dysphagia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anorexia Anorexia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Nausia/Vomiting Nausia/vomiting Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dehydration Dehydration Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
Overall Survival (OS)	81 Percent	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: evaluated every 2 weeks, up to 3 years

Population: Participants enrolled in study

Number of participants with acute grade III/IV treatment-related toxicities

Outcome measures

Measure	Oral Erlotinib Hydrochloride n=43 Participants docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Neutropenia n=43 Participants Neutropenia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anemia n=43 Participants Anemia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Oral Mucositis n=43 Participants Oral mucositis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Radiation Dermatitis n=43 Participants Radiation dermatitis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Acneiform Skin Rash n=43 Participants Acneiform skin rash Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dysphagia n=43 Participants Dysphagia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anorexia n=43 Participants Anorexia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Nausia/Vomiting n=43 Participants Nausia/vomiting Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dehydration n=43 Participants Dehydration Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
Number of Participants With Acute Grade III/IV Treatment-related Toxicities grade 4	17 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Acute Grade III/IV Treatment-related Toxicities Grade 3	24 Participants	2 Participants	3 Participants	14 Participants	15 Participants	4 Participants	20 Participants	13 Participants	7 Participants	2 Participants

SECONDARY outcome

Timeframe: At 3 years

Population: Participants enrolled in study

Participants with Local absence of relapse or recurrence or progression within the prescribed radiation field.

Outcome measures

Measure	Oral Erlotinib Hydrochloride n=43 Participants docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Neutropenia Neutropenia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anemia Anemia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Oral Mucositis Oral mucositis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Radiation Dermatitis Radiation dermatitis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Acneiform Skin Rash Acneiform skin rash Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dysphagia Dysphagia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anorexia Anorexia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Nausia/Vomiting Nausia/vomiting Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dehydration Dehydration Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
Percent of Participants With Local Failure-free Survival	90 percent	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At 3 years

Population: Participants enrolled in study

Participants with the regional absence of relapse or recurrence or progression within the prescribed radiation field. Failure-free Survival percentages were calculated using Kaplan-Meier estimates.

Outcome measures

Measure	Oral Erlotinib Hydrochloride n=43 Participants docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Neutropenia Neutropenia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anemia Anemia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Oral Mucositis Oral mucositis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Radiation Dermatitis Radiation dermatitis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Acneiform Skin Rash Acneiform skin rash Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dysphagia Dysphagia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anorexia Anorexia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Nausia/Vomiting Nausia/vomiting Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dehydration Dehydration Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
Percent of Participants With Regional Failure-free Survival	87.1 percent (Kaplan-Meier estimates)	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At 3 years

Population: Participants enrolled in study

Participants with the locoregional absence of relapse or recurrence or progression within the prescribed radiation field. Locoregional failure-free survival percentages were calculated using Kaplan-Meier estimates.

Outcome measures

Measure	Oral Erlotinib Hydrochloride n=43 Participants docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Neutropenia Neutropenia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anemia Anemia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Oral Mucositis Oral mucositis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Radiation Dermatitis Radiation dermatitis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Acneiform Skin Rash Acneiform skin rash Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dysphagia Dysphagia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anorexia Anorexia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Nausia/Vomiting Nausia/vomiting Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dehydration Dehydration Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
Percent of Participants With Locoregional Failure-free Survival	82.4 percent (Kaplan-Meier estimates)	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At 3 years

Population: Participants enrolled in study

Percent of participants with distant metastasis-free survival

Outcome measures

Measure	Oral Erlotinib Hydrochloride n=43 Participants docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Neutropenia Neutropenia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anemia Anemia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Oral Mucositis Oral mucositis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Radiation Dermatitis Radiation dermatitis Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Acneiform Skin Rash Acneiform skin rash Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dysphagia Dysphagia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Anorexia Anorexia Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Nausia/Vomiting Nausia/vomiting Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week	Dehydration Dehydration Participant intervention: docetaxel: Beginning on week 3, patients receive docetaxel IV over 1 hour once a week
Percent of Participants With Distant Metastasis-free Survival	83.7 percent	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: collection at baseline and periodically during study.

Outcome measures

Outcome data not reported

Adverse Events

Oral Erlotinib Hydrochloride

Serious events: 11 serious events

Other events: 33 other events

Deaths: 11 deaths

Participants From CWRU1301

Serious events: 1 serious events

Other events: 6 other events

Deaths: 4 deaths

Serious adverse events

Measure	Oral Erlotinib Hydrochloride n=37 participants at risk Docetaxel, erlotinib hydrochloride, fluorescence in situ hybridization, polymerase chain reaction, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, therapeutic conventional surgery, intensity-modulated radiation therapy, radiation therapy	Participants From CWRU1301 n=6 participants at risk Participants from CWRU1301 - NCT00049283 who received Docetaxel 20 mg/m2/wk Erlotinib 150 mg/day XRT
Cardiac disorders Palpitations	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Cardiac disorders Cardiac ischemia/infarction	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Colitis	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Constipation	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Dehydration	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Diarrhea	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Dysphagia (difficulty swallowing)	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	10.8% 4/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Hemorrhage, GI - Lower GI	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Cardiac disorders Hypotension	5.4% 2/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Hypoxia	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Psychiatric disorders Insomnia	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reactions	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Nausea	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation - Radiation	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Ulceration	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Cardiac disorders Valvular heart disease	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Vomiting	8.1% 3/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Weight loss	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Cardiac disorders Peripheral arterial ischemia	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)

Other adverse events

Measure	Oral Erlotinib Hydrochloride n=37 participants at risk Docetaxel, erlotinib hydrochloride, fluorescence in situ hybridization, polymerase chain reaction, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, therapeutic conventional surgery, intensity-modulated radiation therapy, radiation therapy	Participants From CWRU1301 n=6 participants at risk Participants from CWRU1301 - NCT00049283 who received Docetaxel 20 mg/m2/wk Erlotinib 150 mg/day XRT
Blood and lymphatic system disorders Hemoglobin	86.5% 32/37 • Number of events 125 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	83.3% 5/6 • Number of events 33 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Cardiac disorders Cardiac ischemia/infarction	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Cardiac disorders Palpitations	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Cardiac disorders Supraventricular and nodal arrhythmia - Sinus tachycardia	13.5% 5/37 • Number of events 7 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Ear and labyrinth disorders Pain - External ear	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Ear and labyrinth disorders Pain - Eye	2.7% 1/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Ear and labyrinth disorders Pain - Middle ear	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Ear and labyrinth disorders Tinnitus	2.7% 1/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Ear and labyrinth disorders Auditory congestion	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Ear and labyrinth disorders Auditory blockage	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Endocrine disorders Thyroid function, low (hypothyroidism)	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Endocrine disorders Endocrine - increased TSH	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Eye disorders Ocular/Visual nonblood	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Eye disorders Itching eyes	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Constipation	40.5% 15/37 • Number of events 26 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Diarrhea	43.2% 16/37 • Number of events 44 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 12 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Distension/bloating, abdominal	2.7% 1/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	62.2% 23/37 • Number of events 34 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Dysphagia (difficulty swallowing)	89.2% 33/37 • Number of events 109 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	100.0% 6/6 • Number of events 20 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Esophagitis	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Heartburn/dyspepsia	43.2% 16/37 • Number of events 31 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Hemorrhage, GI - Oral cavity	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Hemorrhoids	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	81.1% 30/37 • Number of events 119 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Nausea	67.6% 25/37 • Number of events 55 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain - Abdomen	37.8% 14/37 • Number of events 17 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain - Esophagus	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain - Lip	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain - Oral cavity	59.5% 22/37 • Number of events 54 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain - Stomach	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Salivary gland changes/saliva	62.2% 23/37 • Number of events 59 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Vomiting	45.9% 17/37 • Number of events 36 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain - oral cavity, throat	2.7% 1/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Hemorrhage/Bleeding - PEG site	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain associated with swallowing and coughing	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain - tongue	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain - eipgastric	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Pain - mouth and throat	2.7% 1/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders Edema	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders Edema: head and neck	16.2% 6/37 • Number of events 6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders Edema: limb	10.8% 4/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders Fatigue (asthenia, lethargy, malaise)	89.2% 33/37 • Number of events 103 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	100.0% 6/6 • Number of events 19 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	18.9% 7/37 • Number of events 12 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders Pain - Face	24.3% 9/37 • Number of events 10 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders Rigors/chills	24.3% 9/37 • Number of events 11 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders Constitutional Symptoms - nonblood	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Immune system disorders Cytokine release syndrome/acute infusion reaction	2.7% 1/37 • Number of events 6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Eye NOS	2.7% 1/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS	5.4% 2/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)	13.5% 5/37 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Paranasal	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)	13.5% 5/37 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with unknown ANC - Skin (cellulitis)	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection - thrush	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection - clostridium diff.	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection - nonblood	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Injury, poisoning and procedural complications Bruising (in absence of Grade 3 or 4 thrombocytopenia)	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Injury, poisoning and procedural complications Rash: dermatitis associated with radiation - Chemoradiation	78.4% 29/37 • Number of events 89 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Injury, poisoning and procedural complications Rash: dermatitis associated with radiation - Radiation	10.8% 4/37 • Number of events 7 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations Alkaline phosphatase	27.0% 10/37 • Number of events 27 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	43.2% 16/37 • Number of events 32 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	32.4% 12/37 • Number of events 31 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 12 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations Bilirubin (hyperbilirubinemia)	40.5% 15/37 • Number of events 47 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 8 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations Cholesterol, serum-high (hypercholesteremia)	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations Creatinine	21.6% 8/37 • Number of events 11 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations INR (International Normalized Ratio of prothrombin time)	10.8% 4/37 • Number of events 14 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations Leukocytes (total WBC)	51.4% 19/37 • Number of events 89 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 19 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations Lymphopenia	89.2% 33/37 • Number of events 328 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 32 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations Neutrophils/granulocytes (ANC/AGC)	5.4% 2/37 • Number of events 8 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations Platelets	21.6% 8/37 • Number of events 25 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 10 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations PTT (Partial Thromboplastin Time)	2.7% 1/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Investigations Weight loss	81.1% 30/37 • Number of events 84 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	100.0% 6/6 • Number of events 7 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	83.8% 31/37 • Number of events 121 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 16 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Anorexia	75.7% 28/37 • Number of events 80 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	83.3% 5/6 • Number of events 13 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	8.1% 3/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	56.8% 21/37 • Number of events 64 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 14 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Dehydration	35.1% 13/37 • Number of events 18 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	51.4% 19/37 • Number of events 97 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	83.3% 5/6 • Number of events 32 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	16.2% 6/37 • Number of events 11 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 11 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	62.2% 23/37 • Number of events 43 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	27.0% 10/37 • Number of events 12 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	43.2% 16/37 • Number of events 37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	10.8% 4/37 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	35.1% 13/37 • Number of events 25 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	16.2% 6/37 • Number of events 7 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	78.4% 29/37 • Number of events 86 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 8 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Triglyceride, serum-high (hypertriglyceridemia)	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	8.1% 3/37 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Bone growth: spine kyphosis/lordosis	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	8.1% 3/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Pain - Back	27.0% 10/37 • Number of events 14 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Pain - Chest wall	13.5% 5/37 • Number of events 8 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Pain - Chest/thorax	8.1% 3/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	8.1% 3/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Pain - Joint	13.5% 5/37 • Number of events 9 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Pain - Muscle	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Pain - Neck	35.1% 13/37 • Number of events 22 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Pain	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Trismus (difficulty, restriction or pain when opening mouth)	10.8% 4/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Muscle cramps	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Muscle spasm	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Pain - shoulder	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pain - Tumor pain	5.4% 2/37 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Nervous system disorders Dizziness	18.9% 7/37 • Number of events 8 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Nervous system disorders Extrapyramidal/involuntary movement/restlessness	2.7% 1/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Nervous system disorders Neuropathy: motor	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Nervous system disorders Neuropathy: sensory	8.1% 3/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Nervous system disorders Pain - Head/headache	16.2% 6/37 • Number of events 10 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Nervous system disorders Pain - Sinus	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Nervous system disorders Taste alteration (dysgeusia)	45.9% 17/37 • Number of events 45 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 7 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Psychiatric disorders Confusion	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Psychiatric disorders Insomnia	54.1% 20/37 • Number of events 44 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Psychiatric disorders Mood alteration - Agitation	16.2% 6/37 • Number of events 8 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Psychiatric disorders Mood alteration - Anxiety	29.7% 11/37 • Number of events 16 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Psychiatric disorders Mood alteration - Depression	24.3% 9/37 • Number of events 14 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Psychiatric disorders Personality/behavioral	2.7% 1/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Renal and urinary disorders Cystitis	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Renal and urinary disorders Pain - Kidney	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Renal and urinary disorders Urinary frequency/urgency	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Aspiration	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Cough	40.5% 15/37 • Number of events 28 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	18.9% 7/37 • Number of events 15 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	66.7% 4/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	10.8% 4/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Pharynx	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam) - Pharynx	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reactions	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Obstruction/stenosis of airway - Pharynx	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Pain - Throat/pharynx/larynx	73.0% 27/37 • Number of events 78 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 7 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	64.9% 24/37 • Number of events 55 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Chest tightness during Taxotere infusion	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Increased mucous in throat	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Chest pressure	2.7% 1/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Sleep apnea	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Thick sputum	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders Mucous secretion	2.7% 1/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Dry skin	32.4% 12/37 • Number of events 20 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	35.1% 13/37 • Number of events 17 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	50.0% 3/6 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Nail changes	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Pain - Scalp	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Pain - Skin	10.8% 4/37 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Pruritus/itching	48.6% 18/37 • Number of events 33 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Rash/desquamation	32.4% 12/37 • Number of events 24 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	100.0% 6/6 • Number of events 29 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Rash: acne/acneiform	70.3% 26/37 • Number of events 91 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	5.4% 2/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	10.8% 4/37 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Pain - Skin of face	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders small lesion on shaft of penis	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders sebacous cyst on chest	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Vascular disorders Flushing	16.2% 6/37 • Number of events 13 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Vascular disorders Hot flashes/flushes	10.8% 4/37 • Number of events 5 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Vascular disorders Hypertension	5.4% 2/37 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Vascular disorders Hypotension	8.1% 3/37 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Vascular disorders Peripheral vascular disorder	2.7% 1/37 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	0.00% 0/6 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
General disorders unsteady gait	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders Pigmentation changes (e.g., vitiligo)	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders anterior neck irritation	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders sores in nostrils	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders dermatitis/erythema neck, ear (open area), lip	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders sores around mouth/lips	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders cracking fingernails	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders face erythema	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders excoriation at trach site	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders decubitis ulcer, sacral area	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Skin and subcutaneous tissue disorders erythema at PEG tube site	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Endocrine disorders Endocrine-NOS	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Mucositis due to radiation	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	100.0% 6/6 • Number of events 29 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders ulceration, tongue	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders ulcerated R tonsillar bed	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders difficulty chewing	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Gastrointestinal disorders early satiety	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Blood and lymphatic system disorders Hemoptysis	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Blood and lymphatic system disorders Melena/GI bleeding	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Febrile neutropenia	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection with unknown ANC	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Infections and infestations Infection without neutropenia	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 2 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Vascular disorders lymphedema, anterior neck	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders Bicarbonate	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders leg cramps at night	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Metabolism and nutrition disorders muscle tightening in back	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Nervous system disorders Syncope (fainting)	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Eye disorders Conjunctivitis	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 3 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders Arthralgia (joint pain)	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders pain, R lower quadrant	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders neck achiness	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders right neck pain	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders right jaw pain	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders leg pain	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders neck/throat pain	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	33.3% 2/6 • Number of events 4 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders pain - R hip and leg	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders pain, tracheostomy site	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Musculoskeletal and connective tissue disorders pain, PEG tube site	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders moderate obstructive pulmonary disease	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders chest congestion	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders thick secretions	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders nasal drainage	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Respiratory, thoracic and mediastinal disorders difficulty breathing	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
Renal and urinary disorders Urinary retention	0.00% 0/37 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)	16.7% 1/6 • Number of events 1 • Up to 3 years Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)

Additional Information

Dr. Min Yao, MD

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Phone: 1-800-641-2422

Email: CTUReferral@UHhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place