Trial Outcomes & Findings for Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery (NCT NCT03342911)

Last Updated: 2025-04-24

Results Overview

The primary objective of the study is to estimate the rate of pathologic complete response (pCR) at the primary site, defined as the absence of any residual invasive cancer on H\&E evaluation of the resected specimen and all sampled ipsilateral lymph nodes, in patients with newly diagnosed and untreated Stage III-IVA SCCHN of the oral cavity, Oropharynx, Larynx, and Hypopharynx treated with standard neoadjuvant chemotherapy plus Nivolumab, paclitaxel, and carboplatin. Pathologic complete response rate and its associated score 95% confidence interval will be estimated.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Up to 26 months

Results posted on

2025-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Nivolumab, Paclitaxel, Carboplatin) Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV
Overall Study STARTED	34
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Nivolumab, Paclitaxel, Carboplatin) n=34 Participants Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 26 months

Population: The complete pathologic response rate was 45.45% (15/33) with a 95% Confidence Interval of 28.5% to 63.4%.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab, Paclitaxel, Carboplatin) n=33 Participants Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV
Pathologic Complete Response Rate	45.5 percentage of complete response Interval 28.5 to 63.4

SECONDARY outcome

Timeframe: Up to 26 months

Population: number of patients with Major response (Major or complete) was 72.73% (24/33) with a 95% Confidence Interval of 54.2% to 86.1%.

patients achieved the major pathologic response (i.e., \<10% viable tumor) or pathologic complete response

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab, Paclitaxel, Carboplatin) n=33 Participants Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV
Number of Patients Who Achieved Major Pathologic Response (Defined as 10% or Less Residual Viable Tumor)	72.73 percentage of major response Interval 54.2 to 86.1

Adverse Events

Treatment (Nivolumab, Paclitaxel, Carboplatin)

Serious events: 14 serious events

Other events: 34 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Nivolumab, Paclitaxel, Carboplatin) n=34 participants at risk Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV
Blood and lymphatic system disorders Anemia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Hypotension	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Aspiration	14.7% 5/34 • Number of events 5 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders low absolute neutrophil count grade 4	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Chest pain - Cardiac	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders Dehydration	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Diarrhea	2.9% 1/34 • Number of events 4 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Gastric Ulcer	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders lightheaded and anxious	2.9% 1/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Feeding tube dependency	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders Hyperglycemia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Cellulitis	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders Anorexia	2.9% 1/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Muscle weakness - lower limbs	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Stupor	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Sepsis	2.9% 1/34 • Number of events 4 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Seroma	2.9% 1/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Edema	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Hospitalization - Failure to thrive	2.9% 1/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Generalized weakness	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Urinary retention	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Tracheal Hemorrhage	2.9% 1/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Surgical and medical procedures Wound complication	2.9% 1/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Other adverse events

Other adverse events
Measure	Treatment (Nivolumab, Paclitaxel, Carboplatin) n=34 participants at risk Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV
Cardiac disorders abnormal electrocardiogram	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Pain - Abdominal	11.8% 4/34 • Number of events 4 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Abodminal distention	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders acid reflux	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Adrenal insufficiency	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Psychiatric disorders Agitation	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Alanine aminotransferase increased	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Alkaline Phosphatase Increased	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Allergic reaction	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Immune system disorders Alopecia	52.9% 18/34 • Number of events 18 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Anemia	23.5% 8/34 • Number of events 8 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Psychiatric disorders Anorexia	23.5% 8/34 • Number of events 8 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Psychiatric disorders Anxiety	17.6% 6/34 • Number of events 6 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Aphonia	11.8% 4/34 • Number of events 4 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Pain - arm	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Pain - Joint	14.7% 5/34 • Number of events 5 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Aspiration	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Pneumonia - Aspiration	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Aspartate aminotransferase increased	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Arthritis	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Pain - back	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Eye disorders Blurred vision	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Pain - bone	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Pain - chest	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Chest tightness	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Chills	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Impaired concentration	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Confusion	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Constipation	52.9% 18/34 • Number of events 18 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Cough	32.4% 11/34 • Number of events 11 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Death	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders decreased appetite	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders decreased platelet count	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders decreased range of motion	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders Dehydration	11.8% 4/34 • Number of events 4 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Psychiatric disorders Depression	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Diarrhea	76.5% 26/34 • Number of events 26 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders discomfort	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders discomfort - urination & bowel movement	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders dizziness	14.7% 5/34 • Number of events 5 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Drooling	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Dry mouth	17.6% 6/34 • Number of events 6 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders epistaxis	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Dry skin	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Dysarthria	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Dysgeusia	14.7% 5/34 • Number of events 5 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Dysphagia	64.7% 22/34 • Number of events 22 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders Imbalance	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders Ear fullness	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders Pain - ear	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders edema	55.9% 19/34 • Number of events 19 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders Elevated A1C	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders elevated blood cholesterol	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Reproductive system and breast disorders epididymo-orchitis	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Erythema	20.6% 7/34 • Number of events 7 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Fatigue	100.0% 34/34 • Number of events 34 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Febrile Neutropenia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Immune system disorders Fever	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Fibrosis - Deep connective tissue	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Influenza-like illness	11.8% 4/34 • Number of events 4 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Delirium	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Gait disturbance	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Gastroesophageal reflux disease	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Asthenia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Granulocytosis	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders headache	17.6% 6/34 • Number of events 6 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders Hearing loss	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders singultus	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders hypothyroidism	11.8% 4/34 • Number of events 4 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Dysphonia	26.5% 9/34 • Number of events 9 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Hyperglycemia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Hypertension	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Hypertriglyceridemia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders hyperkalemia	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hypomagnesemia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders hypotension	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders hypothyroidism	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hypoxia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Hypersalivation	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders mucous hypersecretion	11.8% 4/34 • Number of events 4 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Cellulitis	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Injury, poisoning and procedural complications Infusion-related reaction	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Injury, poisoning and procedural complications Injection site reaction	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Psychiatric disorders Insomnia	23.5% 8/34 • Number of events 8 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders weakness - lower lip	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Numbness - neck	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders irritation - eyelid	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders left auricle keratosis	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders ear fluid drainage	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Pain - leg	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders weakness - leg	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Reproductive system and breast disorders increased libido	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Presyncope	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Hepatobiliary disorders Hyperlipasemia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Lymphedema	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Immune system disorders Lymphopenia	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Malaise	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders Otalgia	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Halitosis	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Aphthous stomatitis	23.5% 8/34 • Number of events 8 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders oral mucositis	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Myalgia	50.0% 17/34 • Number of events 17 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations rhinitis	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders necrosis - left lateral intra oral free flap	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Neuropathy	23.5% 8/34 • Number of events 8 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Neutropenia	44.1% 15/34 • Number of events 15 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders nocturnal hyperhidrosis	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Pain - oral	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Pain - General	50.0% 17/34 • Number of events 17 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders paresthesia	38.2% 13/34 • Number of events 13 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Peripheral Sensory Neuropathy	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Platelet count decrease	26.5% 9/34 • Number of events 9 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Post nasal drip	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders psoriasis	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Radiation dermatitus	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Rash	47.1% 16/34 • Number of events 16 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Rhinorrhea	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders right elbow redness	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Right Foot drop	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Right shoulder dysfunction	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Mouth Ulcer	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Sepsis	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Seroma	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Serum amylase increased	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Sinus Tachycardia	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Skin lesion	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders soft tissue infection	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Tachycardia	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Pain - Throat	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Thromboembolic event	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Thrush	17.6% 6/34 • Number of events 6 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders Tinnitus	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Tongue Numbness	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Pain - Tongue	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Tracheal Hemorrhage	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Injury, poisoning and procedural complications Tracheostomy site bleeding	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Tremor	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Trismus	8.8% 3/34 • Number of events 3 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Ulceration	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Rash - Upper Chest	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Urinary retention	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Vomiting	11.8% 4/34 • Number of events 4 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Eye disorders Epiphora	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Wheezing	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Weight Change	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders weight gain	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Weight loss	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Leukopenia	29.4% 10/34 • Number of events 10 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Wound	5.9% 2/34 • Number of events 2 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Wound complications	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Wound dehiscence	2.9% 1/34 • Number of events 1 • Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months. An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Additional Information

Jennifer Johnson

Thomas Jefferson University

Phone: 215-955-8874

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place