Trial Outcomes & Findings for Pembrolizumab, Chemotherapy, and Radiation Therapy With or Without Surgery in Treating Patients With Anaplastic Thyroid Cancer (NCT NCT03211117)

NCT ID: NCT03211117

Last Updated: 2020-03-25

Results Overview

Defined as the percentage of evaluable patients who are alive at 6 months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

At 6 months

Results posted on

2020-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A (Pembrolizumab, Surgery, Chemoradiation) Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients undergo surgery. Within 42 days of surgery, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Doxorubicin Hydrochloride: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery	Cohort B (Pembrolizumab, Chemoradiation) Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Doxorubicin Hydrochloride: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Overall Study STARTED	0	3
Overall Study COMPLETED	0	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab, Chemotherapy, and Radiation Therapy With or Without Surgery in Treating Patients With Anaplastic Thyroid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort B (Pembrolizumab, Chemoradiation) n=3 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.\> \> Docetaxel: Given IV\> \> Doxorubicin Hydrochloride: Given IV\> \> Intensity-Modulated Radiation Therapy: Undergo IMRT\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pembrolizumab: Given IV
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 months

Population: All patients

Defined as the percentage of evaluable patients who are alive at 6 months.

Outcome measures

Outcome measures
Measure	Cohort B (Pembrolizumab, Chemoradiation) n=3 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.\> \> Docetaxel: Given IV\> \> Doxorubicin Hydrochloride: Given IV\> \> Intensity-Modulated Radiation Therapy: Undergo IMRT\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pembrolizumab: Given IV
Overall Survival Rate	0 percentage of participants alive

SECONDARY outcome

Timeframe: 2.3 years

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. This data is reported in the adverse events section of this report.

Outcome measures

Outcome measures
Measure	Cohort B (Pembrolizumab, Chemoradiation) n=3 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.\> \> Docetaxel: Given IV\> \> Doxorubicin Hydrochloride: Given IV\> \> Intensity-Modulated Radiation Therapy: Undergo IMRT\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pembrolizumab: Given IV
Incidence of Adverse Events Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2.3 years

Will be summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Cohort B (Pembrolizumab, Chemoradiation) n=3 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity.\> \> Docetaxel: Given IV\> \> Doxorubicin Hydrochloride: Given IV\> \> Intensity-Modulated Radiation Therapy: Undergo IMRT\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pembrolizumab: Given IV
Number of Patients With Locoregional Recurrence and Locoregional Progression in the Thyroid Bed or Regional Lymph Nodes	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Will be summarized using descriptive statistics.

Outcome measures

Outcome data not reported

Adverse Events

Cohort B (Pembrolizumab, Chemoradiation)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Ashish V. Chintakuntlawar, MBBS, Ph.D.

Mayo Clinic

Phone: (855) 776-0015

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort B (Pembrolizumab, Chemoradiation) n=3 participants at risk Pembrolizumab: Given IV	Cohort A Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients undergo surgery. Within 42 days of surgery, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Doxorubicin Hydrochloride: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Gastrointestinal disorders Enterocolitis	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
General disorders Fever	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Infections and infestations Infections and infestations - Other, specify	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Infections and infestations Lung infection	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Infections and infestations Urinary tract infection	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	66.7% 2/3 • Number of events 3 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Respiratory failure	66.7% 2/3 • Number of events 2 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.

Measure	Cohort B (Pembrolizumab, Chemoradiation) n=3 participants at risk Pembrolizumab: Given IV	Cohort A Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 17 courses after chemoradiation if no residual disease is found or for up to 35 courses after chemoradiation if residual disease is found. After 3 days, patients undergo surgery. Within 42 days of surgery, patients also receive docetaxel IV over 1 hour Q1W and doxorubicin hydrochloride IV Q1W, and undergo IMRT once daily 5 days per week for 6.5 weeks in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Doxorubicin Hydrochloride: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
Blood and lymphatic system disorders Anemia	100.0% 3/3 • Number of events 6 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Eye disorders Blurred vision	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Gastrointestinal disorders Dysphagia	66.7% 2/3 • Number of events 3 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Gastrointestinal disorders Mucositis oral	100.0% 3/3 • Number of events 8 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
General disorders Fatigue	100.0% 3/3 • Number of events 7 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Investigations Lymphocyte count decreased	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Investigations Neutrophil count decreased	100.0% 3/3 • Number of events 3 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Investigations Platelet count decreased	66.7% 2/3 • Number of events 5 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Investigations Weight loss	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 3 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hyperkalemia	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hypernatremia	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 2 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hyponatremia	66.7% 2/3 • Number of events 2 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Psychiatric disorders Confusion	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Renal and urinary disorders Urinary frequency	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Sore throat	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Skin and subcutaneous tissue disorders Alopecia	66.7% 2/3 • Number of events 2 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Vascular disorders Superficial thrombophlebitis	33.3% 1/3 • Number of events 1 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.	— 0/0 • 2.3 years The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.