Trial Outcomes & Findings for High Dose Ascorbate With Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas (NCT NCT03508726)
NCT ID: NCT03508726
Last Updated: 2024-06-27
Results Overview
To examine the toxicity related to the therapy by measuring the number attributed adverse event (definite, probable or possible) according to CTCAE version 4.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Start of treatment up to 4 weeks after the last ascorbate infusion
Results posted on
2024-06-27
Participant Flow
Participants were recruited from the Principal Investigator's and Sub-Investigator's clinics at Holden Comprehensive Cancer Center.
Participant milestones
| Measure |
Phase I: Ascorbate 75 mg IV Infusion
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
|
Phase II: Ascorbate 75 mg IV Infusion
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving intravenous (IV) ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
19
|
|
Overall Study
COMPLETED
|
6
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Phase I: Ascorbate 75 mg IV Infusion
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
|
Phase II: Ascorbate 75 mg IV Infusion
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving intravenous (IV) ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
High Dose Ascorbate With Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas
Baseline characteristics by cohort
| Measure |
Phase I: Ascorbate 75 mg IV Infusion
n=6 Participants
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
All participants received 75 mg Ascorbate IV dose three times a week.
|
Phase II: Ascorbate 75 mg IV Infusion
n=19 Participants
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving intravenous (IV) ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
All participants received 75 mg Ascorbate IV dose three times a week.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
67 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
19 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of treatment up to 4 weeks after the last ascorbate infusionPopulation: 6 participants enrolled in the Phase 1 dose escalation portion of the trial and were assessed for dose limiting toxicities. All participants received 75 mg Ascorbate IV dose three times a week.
To examine the toxicity related to the therapy by measuring the number attributed adverse event (definite, probable or possible) according to CTCAE version 4.0.
Outcome measures
| Measure |
Phase I: Ascorbate 75 mg IV Infusion
n=6 Participants
Patients will receive radiation therapy over 5 weeks, during which time they will be receiving ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
|
Phase II: Ascorbate 75 mg IV Infusion
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving intravenous (IV) ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
|
|---|---|---|
|
Number of Participants That Experienced Dose Limiting Toxicities (DLTs) Using CTCAE, Version 4.0
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Start of treatment up to 6 weeks after the last ascorbate infusionPopulation: 6 participants enrolled to the Phase I portion and were assessed for pCR. 18 participants were enrolled to the Phase II portion and assessed by for pCR via pathological reading. All participants in both Phase cohorts received 75 mg Ascorbate IV dose three times a week.
To estimate the efficacy of neoadjuvant ascorbate and radiotherapy as assessed by the pathological complete response rates (pCR) in subjects with locally advanced high grade soft tissue sarcomas.
Outcome measures
| Measure |
Phase I: Ascorbate 75 mg IV Infusion
n=6 Participants
Patients will receive radiation therapy over 5 weeks, during which time they will be receiving ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
|
Phase II: Ascorbate 75 mg IV Infusion
n=18 Participants
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving intravenous (IV) ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
|
|---|---|---|
|
Number of Participants With Pathologic Tumor Necrosis ≥ 95% Following Concurrent Radiation Therapy and Ascorbate
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Enrollment or start of treatment up to 2 years following end of treatmentTime to disease progression (TTP) is defined as the time from enrollment until objective tumor progression including local and distant recurrences.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Enrollment or start of treatment up to 2 years following end of treatmentOverall response rate (ORR) preoperative as measured by RECIST 1.1 or a later tool for monitoring disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Enrollment or start of treatment up to 2 years following end of treatmentOverall survival (OS) rate data gathered through passive chart review, phone call or scheduled follow-up visit and estimated using the Kaplan-Meier Method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within two years following end of treatmentPathologist to grade radiation related skin toxicity overlying the tumor as compared to historical controls. Binomial exact tests will be utilized to identify differences in wound complication and Grade 3-4 dermatitis rates compared to historical controls.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within two years following end of treatmentTo measure labile iron using T2\* imaging sequence on MRI pre and post ascorbate treatments and compare with serum iron measurements
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within two years following end of treatmentTo evaluate diffusion weighted imaging sequences on MRI in pre and post treatment tumors and correlate it with necrosis and survival
Outcome measures
Outcome data not reported
Adverse Events
Phase I: Ascorbate 75 mg IV Infusion
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II: Ascorbate 75 mg IV Infusion
Serious events: 4 serious events
Other events: 18 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Phase I: Ascorbate 75 mg IV Infusion
n=6 participants at risk
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
All participants received 75 mg Ascorbate IV dose three times a week.
|
Phase II: Ascorbate 75 mg IV Infusion
n=19 participants at risk
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving intravenous (IV) ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
All participants received 75 mg Ascorbate IV dose three times a week.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
General disorders
Fever
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
Other adverse events
| Measure |
Phase I: Ascorbate 75 mg IV Infusion
n=6 participants at risk
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
All participants received 75 mg Ascorbate IV dose three times a week.
|
Phase II: Ascorbate 75 mg IV Infusion
n=19 participants at risk
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving intravenous (IV) ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
All participants received 75 mg Ascorbate IV dose three times a week.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
36.8%
7/19 • Number of events 10 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
21.1%
4/19 • Number of events 4 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
21.1%
4/19 • Number of events 5 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Jejunal hemorrhage
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
47.4%
9/19 • Number of events 11 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Rectal pain
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
General disorders
Chills
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
General disorders
Edema limbs
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
26.3%
5/19 • Number of events 6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
26.3%
5/19 • Number of events 5 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
General disorders
Fever
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 4 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
15.8%
3/19 • Number of events 5 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Infections and infestations
Thrush
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
33.3%
2/6 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
15.8%
3/19 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Investigations - Other, specify
|
50.0%
3/6 • Number of events 4 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
42.1%
8/19 • Number of events 26 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
4/6 • Number of events 4 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
36.8%
7/19 • Number of events 14 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
15.8%
3/19 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
Weight loss
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 4 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
26.3%
5/19 • Number of events 5 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
31.6%
6/19 • Number of events 9 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
26.3%
5/19 • Number of events 10 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
31.6%
6/19 • Number of events 9 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
15.8%
3/19 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/6 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
0.00%
0/19 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 2 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
5.3%
1/19 • Number of events 1 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
|
Vascular disorders
Hypertension
|
50.0%
3/6 • Number of events 8 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
10.5%
2/19 • Number of events 3 • For any experience or condition that meets the definition of a adverse event (AE), recording of the event must begin after signing of Informed Consent Form and continue through the 30-day follow up period after treatment is discontinued, up to 12 weeks.
|
Additional Information
Varun Monga, MD
University of Iowa, Holden Comprehensive Cancer Center
Phone: 319-384-9497
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place