Trial Outcomes & Findings for Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis (NCT NCT04252625)

NCT ID: NCT04252625

Last Updated: 2026-01-28

Results Overview

This outcome will report the mean score of the NIH-CPSI, a 13-item questionnaire. This questionnaire will report 4 sub-scores, Pain, Urinary Symptoms, Quality of Life (QOL) Impact, and Pain + Urinary score, and the total score. Pain: The sum of 6 items (0 No-1 Yes), one scale (0 Never-5 Always), and one scale (0 No Pain-10 Pain as bad as you can imagine); Range: 0-21, higher values indicating worse outcomes. Urinary Symptoms: The sum of 2 urine items (0 Not at all-5 Almost always); Range: 0-10, higher values indicating worse outcomes. QOL Impact: The sum of 2 items (0 None-3 A lot) and 1 scale (0 Delighted-6 Terrible); Range: 0-12, higher values indicating worse outcomes. Pain and Urinary sub-score: The sum of the Pan and Urinary Symptoms scores; Range: 0-31, higher values indicating worse outcomes. Total Score: The sum of all questions; Range: 0-43, higher values indicating worse outcomes. This outcome measure is assessed at 6 weeks after the start of study treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: up to 6 weeks after the start of study treatment
• Results posted on: 2026-01-28

Participant Flow

Participant milestones

Measure	Arm 1: Q-Urol Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups will be compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups will be compared. Placebo: placebo capsule
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis

Baseline characteristics by cohort

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups will be compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=5 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups will be compared. Placebo: placebo capsule	Total n=10 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Age, Categorical <=18 years	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=158 Participants	2 Participants n=157 Participants	6 Participants n=315 Participants
Age, Categorical >=65 years	1 Participants n=158 Participants	3 Participants n=157 Participants	4 Participants n=315 Participants
Age, Continuous	62.60 years STANDARD_DEVIATION 6.88 • n=158 Participants	64.00 years STANDARD_DEVIATION 7.81 • n=157 Participants	63.30 years STANDARD_DEVIATION 6.98 • n=315 Participants
Sex: Female, Male Female	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Sex: Female, Male Male	5 Participants n=158 Participants	5 Participants n=157 Participants	10 Participants n=315 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=158 Participants	5 Participants n=157 Participants	10 Participants n=315 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Race (NIH/OMB) Black or African American	0 Participants n=158 Participants	1 Participants n=157 Participants	1 Participants n=315 Participants
Race (NIH/OMB) White	5 Participants n=158 Participants	4 Participants n=157 Participants	9 Participants n=315 Participants
Race (NIH/OMB) More than one race	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Region of Enrollment United States	5 participants n=158 Participants	5 participants n=157 Participants	10 participants n=315 Participants

PRIMARY outcome

Timeframe: up to 6 weeks after the start of study treatment

This outcome will report the mean score of the NIH-CPSI, a 13-item questionnaire.

This questionnaire will report 4 sub-scores, Pain, Urinary Symptoms, Quality of Life (QOL) Impact, and Pain + Urinary score, and the total score.

Pain: The sum of 6 items (0 No-1 Yes), one scale (0 Never-5 Always), and one scale (0 No Pain-10 Pain as bad as you can imagine); Range: 0-21, higher values indicating worse outcomes.

Urinary Symptoms: The sum of 2 urine items (0 Not at all-5 Almost always); Range: 0-10, higher values indicating worse outcomes.

QOL Impact: The sum of 2 items (0 None-3 A lot) and 1 scale (0 Delighted-6 Terrible); Range: 0-12, higher values indicating worse outcomes.

Pain and Urinary sub-score: The sum of the Pan and Urinary Symptoms scores; Range: 0-31, higher values indicating worse outcomes.

Total Score: The sum of all questions; Range: 0-43, higher values indicating worse outcomes.

This outcome measure is assessed at 6 weeks after the start of study treatment.

Outcome measures

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=5 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain score and urinary Score	10 score on a scale Standard Deviation 5.24	10.4 score on a scale Standard Deviation 5.13
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Score	4.00 score on a scale Standard Deviation 4.24	5.8 score on a scale Standard Deviation 4.27
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptoms Score	6.00 score on a scale Standard Deviation 2.55	4.60 score on a scale Standard Deviation 2.51
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of life impact Score	4.80 score on a scale Standard Deviation 1.30	5.20 score on a scale Standard Deviation 2.59
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score	14.80 score on a scale Standard Deviation 6.38	15.60 score on a scale Standard Deviation 7.09

SECONDARY outcome

Timeframe: up to 6 weeks after the start of study treatment

Health Related Quality of Life (HRQOL) will be assessed with EPIC questionnaires. Items are standardized to a 0-100 scale and are averaged to calculate four subscale scores (Urinary Summary, Bowel Summary, Sexual Summary, Hormonal Summary). A higher score (max 100) represents better HRQOL, and a lower score (min 0) represents worse HRQOL.

Outcome measures

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=4 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
The Expanded Prostate Cancer Index Composite (EPIC) Assessment Urinary Summary	68.62 score on a scale Standard Deviation 10.89	64.44 score on a scale Standard Deviation 15.87
The Expanded Prostate Cancer Index Composite (EPIC) Assessment Bowel Summary	85.36 score on a scale Standard Deviation 12.01	84.37 score on a scale Standard Deviation 11.42
The Expanded Prostate Cancer Index Composite (EPIC) Assessment Sexual Summary	26.44 score on a scale Standard Deviation 40.81	23.71 score on a scale Standard Deviation 17.22
The Expanded Prostate Cancer Index Composite (EPIC) Assessment Hormonal Summary	72.02 score on a scale Standard Deviation 17.81	75.03 score on a scale Standard Deviation 12.42

SECONDARY outcome

Timeframe: up to 6 weeks after the start of study treatment

Health Related Quality of Life (HRQOL) will be assessed with International Prostate Symptom Score (I-PSS). This is a questionnaire with 7 questions concerning urinary symptoms (from 0 to 5). A high score (max 35) indicates worse HRQOL and a low score (min 0) represents a better HRQOL. These score are reported as Mild (0-7), moderate (8-19) or Severe (20-35).

total score ranges from 0 to 35 (asymptomatic to very symptomatic).

Outcome measures

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=5 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
The International Prostate Symptom Score (I-PSS) Assessment Severe	3 Participants	1 Participants
The International Prostate Symptom Score (I-PSS) Assessment Mild	0 Participants	0 Participants
The International Prostate Symptom Score (I-PSS) Assessment Moderate	2 Participants	4 Participants

SECONDARY outcome

Timeframe: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.

Health Related Quality of Life (HRQOL) will be assessed with the R-FAS 10-item questionnaires. Question 10 does not count toward the total score. 9 questions are scored from 0-3. A higher score represents poorer bowel function (max 27) and a lower score represents better bowel function (min 0).

Outcome measures

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=5 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
The Rectal Function Assessment Score (R-FAS) Assessment	5.20 Score on a scale Standard Deviation 2.95	3.60 Score on a scale Standard Deviation 3.36

SECONDARY outcome

Timeframe: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.

The SHIM is a 5 point questionnaire with ratings from 0-5 to assess Health Related Quality of Life (HRQOL). The sum of the SHIM score is categorized to Severe Erectile Dysfunction ED (0-7), Moderate ED (8-11), Mild to Moderate ED (12-16), Mild ED (17-21), No signs of ED (22-25).

This outcome will report the count of participants in each category.

Outcome measures

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=5 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
Sexual Health Inventory for Men (SHIM) Assessment Severe Erectile Dysfunction ED (0-7)	3 Participants	3 Participants
Sexual Health Inventory for Men (SHIM) Assessment Moderate ED (8-11)	0 Participants	1 Participants
Sexual Health Inventory for Men (SHIM) Assessment Mild to Moderate ED (12-16)	0 Participants	0 Participants
Sexual Health Inventory for Men (SHIM) Assessment Mild ED (17-21)	0 Participants	1 Participants
Sexual Health Inventory for Men (SHIM) Assessment No signs of ED (22-25)	1 Participants	0 Participants
Sexual Health Inventory for Men (SHIM) Assessment Not assessed	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.

The inflammation marker, erythrocyte sedimentation rate (ESR), was collected at the End of Treatment visit for comparison between treatment and placebo groups. This outcome will report the mean ESR of each arm.

Outcome measures

Measure	Arm 1: Q-Urol n=4 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=4 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
Impact on Serum Biomarkers of Inflammation - Erythrocyte Sedimentation Rate (ESR)	4.50 mm/hour Standard Deviation 1.73	2.50 mm/hour Standard Deviation 1.73

SECONDARY outcome

Timeframe: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.

The inflammation marker, C-reactive protein, was collected at the End of Treatment visit for comparison between treatment and placebo groups.

This outcome will report the mean C-reactive protein of each arm.

Outcome measures

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=4 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
Impact on Serum Biomarkers of Inflammation - C-reactive Protein	0.14 mg/dL Standard Deviation 0.11	0.48 mg/dL Standard Deviation 0.62

SECONDARY outcome

Timeframe: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.

The inflammation marker, Prostate-specific antigen (PSA), was collected at the End of Treatment visit for comparison between treatment and placebo arm.

This outcome will report the mean PSA of each arm.

Outcome measures

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=4 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA)	1.11 ng/ml Standard Deviation 0.90	1.87 ng/ml Standard Deviation 0.92

SECONDARY outcome

Timeframe: up to 10.5 weeks after initiation of study treatment

To assess safety of Q-Urol compared to placebo. The severity of adverse events was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE".

This outcome measure will report the following:

The count of participants who had a grade 1-2 event, related to study treatment.

The count of the participants who had a grade 3-4 event, related to study treatment.

The count of the participants who had a grade 5 event or higher.

Subjects were monitored for adverse events from the start of treatment until 30 days after the last dose of study treatment.

Outcome measures

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=5 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
Adverse Events by Grade Grade 1-2	5 Participants	5 Participants
Adverse Events by Grade Grade 3-4	0 Participants	0 Participants
Adverse Events by Grade Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 28 days after initiation of study treatment

To assess effect on prostatitis-related pain in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo. This outcome will report the mean number of days participants took pain medication as documented on a self reported Pain Management Diary. This was followed for 28 days; the minimum number of days is 0 and the maximum number is 28.

Outcome measures

Measure	Arm 1: Q-Urol n=5 Participants Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=5 Participants Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
Days of Pain Medication	6.00 Pain Medication days Standard Deviation 6.75	5.20 Pain Medication days Standard Deviation 6.30

Adverse Events

Arm 1: Q-Urol

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm 2: Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1: Q-Urol n=5 participants at risk Patients were randomized in a 1:1 ratio to receive Q-Urol, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Q-Urol: Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.	Arm 2: Placebo n=5 participants at risk Patients were randomized in a 1:1 ratio to receive Placebo, two capsules, twice daily for 6 weeks after brachytherapy placement. Questionnaires were administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups were compared. Placebo: placebo capsule
Psychiatric disorders Anxiety	20.0% 1/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Musculoskeletal and connective tissue disorders Bone pain	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Injury, poisoning and procedural complications Bruising	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Constipation	80.0% 4/5 • Number of events 4 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Investigations Creatinine increased	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Psychiatric disorders Depression	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Injury, poisoning and procedural complications Dermatitis radiation	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Diarrhea	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Nervous system disorders Dizziness	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Dry mouth	60.0% 3/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Nervous system disorders Dysgeusia	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Dysphagia	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Nervous system disorders Dysphasia	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Eye disorders Eye disorders - Other, specify	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Injury, poisoning and procedural complications Fall	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
General disorders Fatigue	40.0% 2/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Vascular disorders Hematoma	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Investigations Platelet count decreased	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Immune system disorders Allergic reaction	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Blood and lymphatic system disorders Anemia	60.0% 3/5 • Number of events 5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	60.0% 3/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Metabolism and nutrition disorders Anorexia	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Respiratory, thoracic and mediastinal disorders Hoarseness	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Vascular disorders Hypertension	20.0% 1/5 • Number of events 4 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Metabolism and nutrition disorders Hypokalemia	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Vascular disorders Hypotension	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Investigations Lymphocyte count decreased	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Infections and infestations Mucosal infection	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Mucositis oral	40.0% 2/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	40.0% 2/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	20.0% 1/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Nausea	60.0% 3/5 • Number of events 4 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Musculoskeletal and connective tissue disorders Neck pain	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Oral pain	40.0% 2/5 • Number of events 4 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
General disorders Pain	40.0% 2/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	40.0% 2/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Musculoskeletal and connective tissue disorders Pain in extremity	40.0% 2/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Nervous system disorders Paresthesia	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Injury, poisoning and procedural complications Postoperative hemorrhage	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Injury, poisoning and procedural complications Seroma	20.0% 1/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Respiratory, thoracic and mediastinal disorders Sore throat	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Surgical and medical procedures Surgical and medical procedures - Other, specify	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Infections and infestations Thrush	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Renal and urinary disorders Urinary retention	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Ear and labyrinth disorders Vertigo	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Gastrointestinal disorders Vomiting	40.0% 2/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Investigations Weight loss	20.0% 1/5 • Number of events 2 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	40.0% 2/5 • Number of events 3 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Investigations White blood cell decreased	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Injury, poisoning and procedural complications Wound complication	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	0.00% 0/5 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Injury, poisoning and procedural complications Wound dehiscence	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.
Infections and infestations Wound infection	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.	20.0% 1/5 • Number of events 1 • The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.

Additional Information

IIT Data Management Team

Research Compliance Office, Huntsman Cancer Institute

Phone: 801-213-6215

Email: IITDataManagement@hci.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place