Trial Outcomes & Findings for Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia (NCT NCT03692325)

Last Updated: 2024-10-01

Results Overview

BORR on treatment is the percentage of participants who achieved CR or PR. Best overall response is the best response recorded from study registration until the first disease progression/diagnosis of invasive OSCC (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Best overall response was determined by using composite scores based on both measurement and histology, matching to the response grid as following, (1)CR, a decrease of \>80% or more; (2)PR, a decrease of 40-80%; (3)SD, neither PR or PD, (4)PD, an increase of 10% or more.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Participants were followed up to 164 days.

Results posted on

2024-10-01

Participant Flow

Participants were enrolled from Dec 2018 to Jan 2022.

Participant milestones

Participant milestones
Measure	Nivolumab * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Overall Study STARTED	33
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Nivolumab * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Overall Study Adverse Event	2
Overall Study Progression/Recurrence	2

Baseline Characteristics

Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab n=33 Participants * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Age, Continuous	64.7 Years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants
Race/Ethnicity, Customized White	31 Participants n=5 Participants
ECOG Performance Status (PS) PS 0	30 Participants n=5 Participants
ECOG Performance Status (PS) PS 1	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were followed up to 164 days.

Outcome measures

Outcome measures
Measure	Nivolumab n=33 Participants * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Best Overall Response Rate (BORR)	36.4 percentage of participants Interval 20.4 to 54.9

SECONDARY outcome

Timeframe: Assessed at baseline and end of treatment. Treatment duration in days was a median (range) of 105 (21-164).

Population: This analysis population represents the subset of participants who have completed questionnaires at both baseline and end of treatment.

Quality of Life was evaluated using COMD QLQ (chronic oral mucosal diseases quality of life questionnaire). The range of the possible total score is 0-104, and low score is a good QoL.

Outcome measures

Outcome measures
Measure	Nivolumab n=19 Participants * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
COMD QLQ Score Change From Baseline to End of Treatment	-3 Units on a scale Interval -36.0 to 14.0

SECONDARY outcome

Timeframe: Participants were followed up to 194 days.

The proportion of participants who experienced a maximum grade 1 or 2 adverse events regardless of treatment attribution based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.

Outcome measures

Outcome measures
Measure	Nivolumab n=33 Participants * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Grade 1/2 Toxicity Rate	0.75 proportion of participants Interval 0.58 to 0.89

SECONDARY outcome

Timeframe: Participants were followed up to 194 days.

The proportion of participants who experienced a maximum grade 3 or 4 adverse events regardless of treatment attribution based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.

Outcome measures

Outcome measures
Measure	Nivolumab n=33 Participants * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Grade 3/4 Toxicity Rate	0.21 proportion of participants Interval 0.09 to 0.39

SECONDARY outcome

Timeframe: Participants were followed up to 13.3 months.

Population: This analysis dataset is comprised of the participants who had next surgery.

Time to Next Surgery is defined as time from the first study treatment to any head \& neck surgery or resection for biopsy-proven carcinoma in situ (CIS) or invasive oral carcinoma.

Outcome measures

Outcome measures
Measure	Nivolumab n=5 Participants * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Time to the Next Surgery for a Head and Neck Malignancy	6.5 Months Interval 2.0 to 13.3

SECONDARY outcome

Timeframe: Participants were followed up to 2 years.

CFS2 is the probability of participants remaining alive and cancer-free at 2 years based on Kaplan-Meier methodology. Cancer-Free Survival (CFS) is defined as the time from study registration to development of invasive oral cancer or death due to any cause. Participants alive without disease progression or recurrence (of invasive oral cancer) are censored at date of last disease evaluation.

Outcome measures

Outcome measures
Measure	Nivolumab n=33 Participants * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Cancer Free Survival at 2 Years (CFS2)	0.728 Probability Interval 0.526 to 0.855

SECONDARY outcome

Timeframe: Participants were followed up to 2 years.

2-year OS rate was defined as the percentage of participants alive at 2 years.

Outcome measures

Outcome measures
Measure	Nivolumab n=33 Participants * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
2-year Overall Survival (OS) Rate	100 Percentage of participants Interval 89.4 to 100.0

SECONDARY outcome

Timeframe: PD-L1 CPS assessed at baseline.

PD-L1 CPS (programmed death-1 ligand 1 combined positive score) was calculated by dividing the number of PD-L1 staining cells by the total number of viable tumor cells and then multiplying by 100. Its range of possible values was 0-100, where higher scores were better when participants received PD-L1 targeted therapy.

Outcome measures

Outcome measures
Measure	Nivolumab n=33 Participants * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
PD-L1 Combined Positive Scores (CPS)	10 score on a scale Interval 0.0 to 80.0

Adverse Events

Nivolumab

Serious events: 6 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab n=33 participants at risk * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Cardiac disorders Atrial fibrillation	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Cardiac disorders Atrial flutter	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Cardiac disorders Chest pain - cardiac	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Endocrine disorders Endocrine disorders - Other, specify	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Infections and infestations Hepatitis viral	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Alanine aminotransferase increased	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Aspartate aminotransferase increased	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Blood bilirubin increased	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Cardiac troponin T increased	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Hyperglycemia	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.

Other adverse events

Other adverse events
Measure	Nivolumab n=33 participants at risk * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Cardiac disorders Atrial fibrillation	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Cardiac disorders Chest pain - cardiac	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Cardiac disorders Sinus bradycardia	15.2% 5/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Ear and labyrinth disorders Ear pain	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Endocrine disorders Endocrine disorders - Other, specify	21.2% 7/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Endocrine disorders Hyperthyroidism	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Endocrine disorders Hypothyroidism	60.6% 20/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Eye disorders Blurred vision	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Eye disorders Dry eye	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Eye disorders Eye disorders - Other, specify	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Eye disorders Floaters	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Eye disorders Glaucoma	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Eye disorders Periorbital edema	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Eye disorders Vision decreased	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Eye disorders Watering eyes	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Abdominal pain	12.1% 4/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Constipation	15.2% 5/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Diarrhea	33.3% 11/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Dry mouth	12.1% 4/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Dysphagia	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Gastritis	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Gastroesophageal reflux disease	18.2% 6/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	18.2% 6/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Mucositis oral	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Nausea	21.2% 7/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Oral cavity fistula	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Oral pain	57.6% 19/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Gastrointestinal disorders Vomiting	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Edema face	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Edema limbs	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Facial pain	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Fatigue	84.8% 28/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Fever	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Flu like symptoms	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders General disorders and administration site conditions - Other, specify	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Malaise	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Non-cardiac chest pain	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
General disorders Pain	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Immune system disorders Immune system disorders - Other, specify	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Infections and infestations Skin infection	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Infections and infestations Thrush	12.1% 4/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Infections and infestations Wound infection	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Injury, poisoning and procedural complications Infusion related reaction	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Alanine aminotransferase increased	33.3% 11/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Alkaline phosphatase increased	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Aspartate aminotransferase increased	36.4% 12/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Cholesterol high	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Creatinine increased	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Neutrophil count decreased	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Thyroid stimulating hormone increased	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations Weight gain	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Investigations White blood cell decreased	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Anorexia	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Dehydration	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Hyperglycemia	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Hyperkalemia	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Hyperlipidemia	33.3% 11/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Hypokalemia	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Hyponatremia	15.2% 5/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Metabolism and nutrition disorders Hypophosphatemia	24.2% 8/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Musculoskeletal and connective tissue disorders Arthralgia	30.3% 10/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Musculoskeletal and connective tissue disorders Arthritis	18.2% 6/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Musculoskeletal and connective tissue disorders Back pain	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Musculoskeletal and connective tissue disorders Muscle cramp	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Musculoskeletal and connective tissue disorders Myalgia	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Musculoskeletal and connective tissue disorders Osteoporosis	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Musculoskeletal and connective tissue disorders Pain in extremity	12.1% 4/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Musculoskeletal and connective tissue disorders Trismus	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Nervous system disorders Dizziness	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Nervous system disorders Dysarthria	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Nervous system disorders Dysgeusia	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Nervous system disorders Dysphasia	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Nervous system disorders Headache	30.3% 10/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Nervous system disorders Peripheral sensory neuropathy	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Nervous system disorders Tremor	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Psychiatric disorders Anxiety	24.2% 8/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Psychiatric disorders Depression	12.1% 4/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Psychiatric disorders Insomnia	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Psychiatric disorders Irritability	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Renal and urinary disorders Renal and urinary disorders - Other, specify	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Renal and urinary disorders Urinary incontinence	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Renal and urinary disorders Urine discoloration	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Reproductive system and breast disorders Erectile dysfunction	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Reproductive system and breast disorders Genital edema	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Reproductive system and breast disorders Pelvic pain	6.1% 2/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Reproductive system and breast disorders Vaginal hemorrhage	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Reproductive system and breast disorders Vaginal pain	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Cough	24.2% 8/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Dyspnea	30.3% 10/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 3/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Productive cough	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Sinus disorder	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Sleep apnea	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Sore throat	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Respiratory, thoracic and mediastinal disorders Voice alteration	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Skin and subcutaneous tissue disorders Eczema	15.2% 5/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Skin and subcutaneous tissue disorders Erythema multiforme	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Skin and subcutaneous tissue disorders Nail discoloration	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Skin and subcutaneous tissue disorders Pruritus	33.3% 11/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Skin and subcutaneous tissue disorders Rash acneiform	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.0% 1/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	42.4% 14/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
Vascular disorders Hypertension	51.5% 17/33 • All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv4.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.

Additional Information

Glenn Hanna, MD

Dana-Farber Cancer Institute

Phone: 617-632-3090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place