Trial Outcomes & Findings for Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma (NCT NCT02641093)

Last Updated: 2024-08-29

Results Overview

Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation. Compared as percentage of grade 3 and 4 adverse events with historical control percentages.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution.

Results posted on

2024-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab * Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin. * Pembrolizumab: Pembrolizumab administered intravenously one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. The dose is 200 mg every three weeks. * Surgery: gross total surgical resection * Radiation Therapy: 60-66 Gy over 6 weeks * Cisplatin: administered intravenously at 40 mg/m2 weekly during radiation therapy for 6 doses only for patients with high-risk pathological features
Overall Study STARTED	96
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=92 Participants Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	28 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	2 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=92 Participants Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Number of Participants With Treatment Related Adverse Effects	78 Participants

PRIMARY outcome

Timeframe: 1 year

Population: • High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.

• High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=44 Participants Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation	66 percentage of high risk participants Interval 55.0 to 84.0

PRIMARY outcome

Timeframe: 1 year

Population: • Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins.

• Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=31 Participants Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation	96 percentage of intermediate participants Interval 90.0 to 100.0

SECONDARY outcome

Timeframe: 1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken

Change in distribution of the tumor immune microenvironment after Pembrolizumab administration in tumor biopsy tissue using markers of T cells and T cell activation using PD-L1 CPS. PD-L1 CPS is defined as the PD-L1 combined positive score. PD-L1 CPS is defined as Combined positivity score (CPS) was calculated by summing the numbers of PD-L1-positive tumor cells and immune cells and dividing by the total number of viable tumor cells. Additionally, PD-L1 is a protein that helps the body immune system remain in control. The denominator in this case is 72 subjects that were evaluable. Evaluable means the subject had a pre-surgery pembrolizumab and a biopsy taken. The numerators are explained below.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=72 Participants Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue PD-L1 CPS in Baseline tumor tissue was zero	20 Participants
Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue PD-L1 CPS in Baseline tumor tissue was ≥1	52 Participants

SECONDARY outcome

Timeframe: 1 year

Population: • Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins

• Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins

Outcome measures

Outcome measures
Measure	Pembrolizumab n=31 Participants Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation	100 percentage of intermediate participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 1 year

Population: • High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.

• High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=44 Participants Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation	93 percentage of high risk participants Interval 85.0 to 100.0

Adverse Events

Pembrolizumab

Serious events: 43 serious events

Other events: 92 other events

Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab n=96 participants at risk Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Renal and urinary disorders Acute Kidney Injury	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Endocrine disorders Adrenal insufficiency	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Blood and lymphatic system disorders Anemia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Anorectal infection	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Anorexia	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Aspiration	5.2% 5/96 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Atrial fibrillation	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Bone infection	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Cardiac arrest	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Chest pain - cardiac	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Colitis	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Constipation	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Dehydration	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders Delirium	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Diarrhea	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Edema face	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Enterocolitis infectious	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Fall	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Blood and lymphatic system disorders Febrile neutropenia	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders Hematoma	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypercalcemia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hyperglycemia	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypophosphatemia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Infections and infestations - Other, specify	4.2% 4/96 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Laryngeal fistula	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Blood and lymphatic system disorders Leukocytosis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Lung infection	4.2% 4/96 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	3.1% 3/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Mucositis oral	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Myocardial infarction	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Nausea	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Neutrophil count decreased	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Pain	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Pancreatitis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Pharyngeal fistula	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Salivary gland infection	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Sinusitis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Immune system disorders Skin infection	4.2% 4/96 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Surgical and medical procedures Surgical and medical procedures - Other, specify	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Syncope	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Tracheal obstruction	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Tracheitis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Urinary tract infection	1.0% 1/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Venous injury	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Vomiting	3.1% 3/96 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Wound complication	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Wound dehiscence	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Wound infection	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.

Other adverse events

Other adverse events
Measure	Pembrolizumab n=96 participants at risk Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Gastrointestinal disorders Abdominal distension	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Abdominal pain	8.3% 8/96 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Activated partial thromboplastin time prolonged	4.2% 4/96 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Renal and urinary disorders acute kidney injury	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Endocrine disorders Adrenal insufficiency	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders agitation	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Alanine aminotransferase increased	10.4% 10/96 • Number of events 14 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Alkaline phosphatase increased	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Immune system disorders Allergic reaction	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders allergic rhinitis	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders alopecia	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Blood and lymphatic system disorders Anemia	32.3% 31/96 • Number of events 67 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Anorexia	29.2% 28/96 • Number of events 43 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders Anxiety	18.8% 18/96 • Number of events 22 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Aphonia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Arthralgia	5.2% 5/96 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Arthritis	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Aspartate aminotransferase increased	8.3% 8/96 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Aspiration	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Atrial flutter	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Immune system disorders Autoimmune disorder	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Back Pain	6.2% 6/96 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	9.4% 9/96 • Number of events 9 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Blood bilirubin increased	1.0% 1/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Eye disorders Blurred vision	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Bone infection	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Bruising	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Bullous dermatitis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Burn	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders cardiac disorders other specify	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations CD4 lymphocytes decreased	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Chest pain - cardiac	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Chills	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Renal and urinary disorders Chronic kidney disease	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Colitis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Concentration impairment	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders confusion	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Eye disorders conjunctivitis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Constipation	42.7% 41/96 • Number of events 49 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Cough	20.8% 20/96 • Number of events 22 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Creatinine increased	11.5% 11/96 • Number of events 14 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Renal and urinary disorders Cystitis noninfective	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Dehydration	16.7% 16/96 • Number of events 21 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders Delirium	2.1% 2/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Dental Caries	4.2% 4/96 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders Depression	12.5% 12/96 • Number of events 16 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Dermatitis radiation	47.9% 46/96 • Number of events 66 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Diarrhea	25.0% 24/96 • Number of events 29 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Dizziness	14.6% 14/96 • Number of events 14 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Eye disorders Dry eye	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Dry mouth	37.5% 36/96 • Number of events 43 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Dry skin	4.2% 4/96 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Duodenal hemorrhage	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Dysarthria	12.5% 12/96 • Number of events 15 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Dysgeusia	35.4% 34/96 • Number of events 45 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Dyspepsia	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Dysphagia	58.3% 56/96 • Number of events 97 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.5% 13/96 • Number of events 17 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Ear and labyrinth disorders Ear pain	6.2% 6/96 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Edema face	33.3% 32/96 • Number of events 40 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Edema limbs	10.4% 10/96 • Number of events 11 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Encephalopathy	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Endocrine disorders Endocrine disorders - Other, specify	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Erythema multiforme	10.4% 10/96 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Esophageal pain	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Eye disorders eye disorders - other, specify	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Eye disorders Eyelid function disorder	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Facial pain	7.3% 7/96 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Fall	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Fatigue	66.7% 64/96 • Number of events 75 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Blood and lymphatic system disorders Febrile neutropenia	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Fever	9.4% 9/96 • Number of events 11 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Fibrinogen decreased	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Flatulence	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Flu like symptoms	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Fracture	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Gastroesophageal reflux disease	7.3% 7/96 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	35.4% 34/96 • Number of events 35 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders General disorders and administration site conditions - Other, specify	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.1% 3/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Glucose intolerance	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders Hallucinations	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders head soft tissue necrosis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Headache	11.5% 11/96 • Number of events 12 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Ear and labyrinth disorders Hearing impaired	5.2% 5/96 • Number of events 8 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Heart failure	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders hematoma	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Renal and urinary disorders Hematuria	5.2% 5/96 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders hemorrhoids	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Hepatobiliary disorders Hepatic failure	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Hepatitis viral	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders Vascular disorders - other, specify	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Hiccups	2.1% 2/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Hip fracture	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Hoarseness	6.2% 6/96 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders Hot flashes	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypercalcemia	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hyperglycemia	13.5% 13/96 • Number of events 23 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hyperkalemia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypermagnesemia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypernatremia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders Hypertension	8.3% 8/96 • Number of events 19 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Endocrine disorders Hyperthyroidism	6.2% 6/96 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hyperuricemia	4.2% 4/96 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypoalbuminemia	6.2% 6/96 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypocalcemia	6.2% 6/96 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypoglycemia	1.0% 1/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypokalemia	16.7% 16/96 • Number of events 22 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypomagnesemia	18.8% 18/96 • Number of events 22 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hyponatremia	12.5% 12/96 • Number of events 23 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Endocrine disorders Hypoparathyroidism	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Hypophosphatemia	9.4% 9/96 • Number of events 15 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders Hypotension	11.5% 11/96 • Number of events 12 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Endocrine disorders Hypothyroidism	13.5% 13/96 • Number of events 14 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.1% 2/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Immune system disorders Immune system disorders - Other, specify	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Infections and infestations - Other, specify	42.7% 41/96 • Number of events 47 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Infusion related reaction	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	20.8% 20/96 • Number of events 20 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations INR increased	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders Insomnia	20.8% 20/96 • Number of events 20 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Investigations - Other, specify	7.3% 7/96 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Blood and lymphatic system disorders Leukocytosis	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations lip infection	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Lip pain	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Lipohypertrophy	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Localized edema	15.6% 15/96 • Number of events 15 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Lung infection	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders Lymphedema	30.2% 29/96 • Number of events 32 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Lymphocyte count decreased	11.5% 11/96 • Number of events 39 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Lymphocyte count increased	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders memory impairment	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Meningismus	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	5.2% 5/96 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Movements involuntary	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Mucosal infection	8.3% 8/96 • Number of events 9 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Mucositis oral	51.0% 49/96 • Number of events 81 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Muscle cramp	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	25.0% 24/96 • Number of events 26 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Myalgia	5.2% 5/96 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Nail infection	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Nausea	43.8% 42/96 • Number of events 60 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Neck edema	16.7% 16/96 • Number of events 19 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Neck pain	28.1% 27/96 • Number of events 30 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	7.3% 7/96 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Nervous system disorders - Other, specify	10.4% 10/96 • Number of events 12 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Neutrophil count decreased	16.7% 16/96 • Number of events 19 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Non-cardiac chest pain	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders oral cavity fistula	6.2% 6/96 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Oral dysesthesia	6.2% 6/96 • Number of events 6 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Oral hemorrhage	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Oral pain	35.4% 34/96 • Number of events 43 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Osteoporosis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
General disorders Pain	28.1% 27/96 • Number of events 31 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Pain in extremity	13.5% 13/96 • Number of events 18 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Papulopustular rash	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Paresthesia	16.7% 16/96 • Number of events 17 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Periodontal disease	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Peripheral motor neuropathy	3.1% 3/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Peripheral sensory neuropathy	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Pharyngeal fistula	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders Phlebitis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Eye disorders photophobia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Platelet count decreased	13.5% 13/96 • Number of events 17 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Postnasal drip	4.2% 4/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Postoperative hemorrhage	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Presyncope	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Productive cough	6.2% 6/96 • Number of events 8 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Reproductive system and breast disorders Prostatic pain	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Renal and urinary disorders Proteinuria	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Pruritus	6.2% 6/96 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders Psychiatric disorders - Other, specify	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders Psychosis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders pulmonary edema	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Rash acneiform	9.4% 9/96 • Number of events 11 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.5% 11/96 • Number of events 13 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Rash pustular	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders rectal pain	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Renal and urinary disorders Renal and urinary disorders - Other, specify	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	12.5% 12/96 • Number of events 21 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Salivary duct inflammation	14.6% 14/96 • Number of events 14 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Scalp pain	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications seroma	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Sinus bradycardia	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Sinus disorder	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Sinus tachycardia	12.5% 12/96 • Number of events 14 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Sinusitis	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	18.8% 18/96 • Number of events 19 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders skin hyperpigmentation	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders skin induration	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Skin infection	7.3% 7/96 • Number of events 7 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Skin ulceration	4.2% 4/96 • Number of events 5 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Sleep apnea	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Soft tissue infection	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Somnolence	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Sore throat	28.1% 27/96 • Number of events 37 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders stomach pain	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Stridor	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Psychiatric disorders suicidal ideation	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Superficial soft tissue fibrosis	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders Superficial thrombophlebitis	1.0% 1/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Supraventricular tachycardia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Surgical and medical procedures Surgical and Medical Procedure - Other, specify	8.3% 8/96 • Number of events 8 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Syncope	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Vascular disorders Thromboembolic event	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Ear and labyrinth disorders Tinnitus	15.6% 15/96 • Number of events 16 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Toothache	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Tracheal fistula	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Tracheal obstruction	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Trigeminal nerve disorder	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Musculoskeletal and connective tissue disorders Trismus	20.8% 20/96 • Number of events 24 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	2.1% 2/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Renal and urinary disorders Urinary frequency	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Renal and urinary disorders Urinary retention	3.1% 3/96 • Number of events 3 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Urinary tract infection	5.2% 5/96 • Number of events 8 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Skin and subcutaneous tissue disorders Urticaria	2.1% 2/96 • Number of events 2 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Nervous system disorders Vasovagal reaction	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Cardiac disorders Ventricular tachycardia	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Voice alteration	11.5% 11/96 • Number of events 12 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Gastrointestinal disorders Vomiting	21.9% 21/96 • Number of events 30 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Weight gain	1.0% 1/96 • Number of events 1 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations Weight loss	50.0% 48/96 • Number of events 110 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Respiratory, thoracic and mediastinal disorders Wheezing	3.1% 3/96 • Number of events 4 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Investigations White blood cell decreased	13.5% 13/96 • Number of events 18 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Wound complication	8.3% 8/96 • Number of events 10 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Injury, poisoning and procedural complications Wound dehiscence	9.4% 9/96 • Number of events 11 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
Infections and infestations Wound Infection	9.4% 9/96 • Number of events 9 • All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months. Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.

Additional Information

Trisha Wise-Draper, MD, PhD

University of Cincinnati

Phone: 513 558 2826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication but has the right to delay or extend publication or presentation timeframes for a period not to exceed 60 days after the initial review period when this would impact sponsor's ability to obtain patent protection.
Publication restrictions are in place

Restriction type: OTHER