Trial Outcomes & Findings for Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)" (NCT NCT03621696)
NCT ID: NCT03621696
Last Updated: 2026-04-21
Results Overview
* Weight in kilograms will be collected weekly during radiation * The percent weight loss from the baseline is calculated at any post-baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
Arm 3: POACRT
* Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Not Assigned to an Arm
-Patients were enrolled to the study but deemed ineligible to start treatment and were not enrolled to any arm.
|
Arm 1: POAmCRT
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 2: POAmRT
* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
21
|
31
|
|
Overall Study
COMPLETED
|
4
|
0
|
20
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 3: POACRT
* Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Not Assigned to an Arm
-Patients were enrolled to the study but deemed ineligible to start treatment and were not enrolled to any arm.
|
Arm 1: POAmCRT
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 2: POAmRT
* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
|---|---|---|---|---|
|
Overall Study
Not eligible
|
0
|
5
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"
Baseline characteristics by cohort
| Measure |
Arm 3: POACRT
n=6 Participants
* Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Not Assigned to an Arm
n=5 Participants
-Patients were enrolled to the study but deemed ineligible to start treatment and were not enrolled to any arm.
|
Total
n=63 Participants
Total of all reporting groups
|
Arm 1: POAmCRT
n=21 Participants
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 2: POAmRT
n=31 Participants
* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=26 Participants
|
57 years
n=15 Participants
|
58 years
n=25 Participants
|
56 years
n=13 Participants
|
58 years
n=13 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
5 Participants
n=25 Participants
|
1 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=26 Participants
|
5 Participants
n=15 Participants
|
58 Participants
n=25 Participants
|
20 Participants
n=13 Participants
|
27 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=26 Participants
|
5 Participants
n=15 Participants
|
61 Participants
n=25 Participants
|
20 Participants
n=13 Participants
|
30 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=25 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=26 Participants
|
5 Participants
n=15 Participants
|
60 Participants
n=25 Participants
|
19 Participants
n=13 Participants
|
31 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=26 Participants
|
5 participants
n=15 Participants
|
63 participants
n=25 Participants
|
21 participants
n=13 Participants
|
31 participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)Population: 1 participant not evaluable in Arm 2 and 2 participants not evaluable in Arm 3 as they didn't receive CRT.
* Weight in kilograms will be collected weekly during radiation * The percent weight loss from the baseline is calculated at any post-baseline
Outcome measures
| Measure |
Arm 1: POAmCRT
n=20 Participants
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 2: POAmRT
n=30 Participants
* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 3: POACRT
n=4 Participants
* Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
|---|---|---|---|
|
Mean Percent Weight Change
|
-4.89 percent of change
Interval -6.24 to -3.54
|
-3.18 percent of change
Interval -4.19 to -2.17
|
-10.11 percent of change
Interval -15.79 to -4.43
|
SECONDARY outcome
Timeframe: Through completion of follow-up (approximately 63 months)-95% confidence intervals will be calculated assuming a binomial distribution
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 weeks after POAmCRT (approximately 90 days)Population: 1 participant not evaluable in Arm 2 and 2 participants not evaluable in Arm 3 as they didn't receive CRT.
Outcome measures
| Measure |
Arm 1: POAmCRT
n=21 Participants
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 2: POAmRT
n=30 Participants
* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 3: POACRT
n=4 Participants
* Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
|---|---|---|---|
|
Change in Serum Creatinine
|
0.03 mg/dL
Standard Deviation 0.09
|
0.08 mg/dL
Standard Deviation 0.22
|
-0.19 mg/dL
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: 6 weeks after POAmCRT (approximately 90 days)Population: 1 participant not evaluable in Arm 2 and 2 participants not evaluable in Arm 3 as they didn't receive CRT.
-95% confidence intervals will be calculated assuming a binomial distribution
Outcome measures
| Measure |
Arm 1: POAmCRT
n=20 Participants
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 2: POAmRT
n=30 Participants
* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 3: POACRT
n=4 Participants
* Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
|---|---|---|---|
|
Percentage of Participants Taking Narcotics
|
40 percentage of participants
Interval 16.5 to 63.5
|
20 percentage of participants
Interval 4.8 to 35.2
|
75 percentage of participants
Interval 54.6 to 100.0
|
SECONDARY outcome
Timeframe: 24 months post-treatment (approximately 27 months)Outcome measures
| Measure |
Arm 1: POAmCRT
n=20 Participants
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 2: POAmRT
n=30 Participants
* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 3: POACRT
n=4 Participants
* Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
|---|---|---|---|
|
Disease Recurrence Rate
|
2 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Through completion of follow-up (approximately 63 months)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through completion of follow-up (approximately 63 months)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline through one year after completion of treatment (approximately 15 months)-10-item self-administered questionnaire, which was designed to assess "quality of life related to shoulder dysfunction" after neck dissection. A 5-point response option (1 to 5) is provided for each item, with 1 being the most disability and 5 the least disability. The responses for all 10 items are added together to produce a raw score, which is then transformed to a score of 100 maximum. Higher scores represent less disability. --Captured at baseline, interim assessment (14-42 days post-surgery), Day 1 of radiation, Day 21 after start of radiation, Day 36 after start of radiation, and 6 weeks/4 months/6 months/12 months after completion of adjuvant therapy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline through one year after completion of treatment (approximately 15 months)-Measures total taste acuity with the patient choosing the appropriate answer ranging from 0=same taste acuity as before treatment to 4=almost complete or complete loss of taste acuity
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline through one year after completion of treatment (approximately 15 months)* Measures impact of salivary gland dysfunction \& xerostomia. Scale consists of 15 items covering 4 major domains of oral health-related quality of life: physical functioning, personal/psychological functioning, social functioning, \& pain/discomfort issues * Patients answer the questions by checking the box that describes the best statement for the past 7 days (not at all, a little, somewhat, quite a bit, very much), 1-5 scale. Higher scores represent greater degree of symptoms. Physical functioning based upon responses to items 1, 6, 10, 12. Pain/discomfort issues based upon responses to items 2, 3, 7, 9. Personal/psychological functioning based upon responses to items 8, 13, 14, 15. Social functioning based upon responses to items 4, 5, 11 * Captured at baseline, interim assessment (14-42 days post-surgery), Day 1 of radiation, Day 21 after start of radiation, Day 36 after start of radiation, \& 6 weeks/4 months/6 months/12 months after completion of adjuvant therapy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline through one year after completion of treatment (approximately 15 months)* Consists of 20 items. Besides a global assessment (a single question), it comprises three subscales: the emotional subscale (8 items), the functional subscale (5 items), and the physical subscale (6 items). The global assessment refers to the individual's swallowing difficulty as it affects one's overall daily routine. The emotional, functional, and physical subscales refer to the individual's affective response to the swallowing disorder, the impact of the disorder on daily activities, and the self-perception of the swallowing difficulties, respectively. Using a five-point scale (1-5), the minimum total score is 20 and the maximum 100 * Captured at baseline, interim assessment (14-42 days post-surgery), Day 1 of radiation, Day 21 after start of radiation, Day 36 after start of radiation, and 6 weeks/4 months/6 months/12 months after completion of adjuvant therapy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline through one year after completion of treatment (approximately 15 months)* Consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for head and neck related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as an global QoL score. Higher scores represent better QoL. * Captured at baseline, interim assessment (14-42 days post-surgery), Day 1 of radiation, Day 21 after start of radiation, Day 36 after start of radiation, and 6 weeks/4 months/6 months/12 months after completion of adjuvant therapy
Outcome measures
Outcome data not reported
Adverse Events
Arm 3: POACRT
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 1: POAmCRT
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm 2: POAmRT
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 3: POACRT
n=6 participants at risk
* Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 1: POAmCRT
n=21 participants at risk
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 2: POAmRT
n=31 participants at risk
* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
G-tube pain
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Chyle leak
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
6.5%
2/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Cardiac disorders
Atrial flutter
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
Other adverse events
| Measure |
Arm 3: POACRT
n=6 participants at risk
* Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 1: POAmCRT
n=21 participants at risk
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
Arm 2: POAmRT
n=31 participants at risk
* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
23.8%
5/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
16.1%
5/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
5/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
38.1%
8/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
45.2%
14/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
66.7%
4/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
66.7%
14/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
71.0%
22/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
66.7%
4/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
61.9%
13/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
87.1%
27/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
66.7%
4/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
66.7%
14/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
67.7%
21/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
42.9%
9/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
22.6%
7/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Oral hemmorrhage
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
12.9%
4/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
General disorders
Chills
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
General disorders
Edema face
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
12.9%
4/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
General disorders
Facial pain
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
57.1%
12/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
45.2%
14/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
General disorders
Neck edema
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
General disorders
Pain
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
6.5%
2/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
19.0%
4/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
16.1%
5/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Investigations
Creatinine increased
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
12.9%
4/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Investigations
INR increased
|
50.0%
3/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
4/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
66.7%
14/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
71.0%
22/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Investigations
Neutrophil count decreased
|
50.0%
3/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
14.3%
3/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Investigations
Platelet count decreased
|
50.0%
3/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
14.3%
3/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.7%
3/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Investigations
Weight loss
|
83.3%
5/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
76.2%
16/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
58.1%
18/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Investigations
White blood cell decreased
|
50.0%
3/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
38.1%
8/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
22.6%
7/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
19.4%
6/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
6.5%
2/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
19.0%
4/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.7%
3/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
14.3%
3/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
16.1%
5/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
6.5%
2/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
6.5%
2/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.7%
3/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
6.5%
2/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right sided
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
6.5%
2/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.7%
3/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
6.5%
2/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
14.3%
3/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
57.1%
12/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
61.3%
19/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
6.5%
2/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
28.6%
6/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
19.4%
6/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
3.2%
1/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Vascular disorders
Hematoma
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
4.8%
1/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
47.6%
10/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
29.0%
9/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/6 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
9.5%
2/21 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
0.00%
0/31 • Adverse events were collected from start of treatment through 6 weeks post-end of adjuvant therapy visit.
All-cause mortality, serious adverse events, and other (not including serious) adverse events were not collected for the Not Assigned to an Arm group as these participants did not receive any study treatment.
|
Additional Information
Douglas Adkins, M.D.
Washington University School of Medicine
Phone: 314-747-8475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place