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: 2026-06-18
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
2026-06-18
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 |
Total
n=25 Participants
Total of all reporting groups
|
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.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=40 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
|
Age, Continuous
|
65 years
n=40 Participants
|
60 years
n=20 Participants
|
67 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=40 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=40 Participants
|
2 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=40 Participants
|
6 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=40 Participants
|
5 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=40 Participants
|
6 participants
n=20 Participants
|
19 participants
n=20 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. 19 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=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.
|
|---|---|---|
|
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 treatmentEvent-free survival is defined as the time from treatment initiation until progression which precludes surgery, recurrence or death due to any cause. Otherwise, patients are censored at last disease assessment.
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=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.
|
|---|---|---|
|
Event-Free Survival at 2 Years
|
100 Cumulative Probability
Interval 100.0 to 100.0
|
46 Cumulative Probability
Interval 23.0 to 67.0
|
SECONDARY outcome
Timeframe: Enrollment or start of treatment up to 2 years following end of treatmentOverall response rate (ORR) is the percentage of patients with a complete or partial response preoperatively as measured by RECIST 1.1 or a later tool for monitoring disease progression.
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=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.
|
|---|---|---|
|
Overall Response Rate
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Enrollment or start of treatment up to 2 years following end of treatmentOverall survival is defined as the time from treatment initiation to death due to any cause. Patients still alive are censored at last date known to be alive.
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=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.
|
|---|---|---|
|
Overall Survival at 2 Years
|
100 Cumulative Probability
Interval 100.0 to 100.0
|
74 Cumulative Probability
Interval 48.0 to 88.0
|
SECONDARY outcome
Timeframe: Within two years following end of treatmentPathologist to grade radiation related skin toxicity.
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=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.
|
|---|---|---|
|
Skin Toxicity
Grade 0
|
4 participants
|
9 participants
|
|
Skin Toxicity
Grade 1
|
1 participants
|
2 participants
|
|
Skin Toxicity
Grade 2
|
1 participants
|
6 participants
|
|
Skin Toxicity
Grade 3
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Within two years following end of treatmentPopulation: This outcome measure required both T2\* MRI imaging and serum iron measurements within the protocol-defined window. T2\* imaging was performed in a limited subset of participants. Serum iron measurements required for this endpoint were not obtained for participants who underwent T2\* imaging. As a result, no participants had both evaluable T2\* imaging and serum iron data; therefore, 0 participants were included in the analysis population and no outcome data are available for reporting.
To measure labile iron using T2\* imaging sequence on MRI pre and post ascorbate treatments and compare with serum iron measurements
Outcome measures
| Measure |
Phase I: Ascorbate 75 mg IV Infusion
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.
|
|---|---|---|
|
Labile Iron
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within two years following end of treatmentPopulation: The diffusion weighted images obtained were not of high enough quality to be evaluated. Thus, analyses could not be conducted.
To evaluate diffusion weighted imaging sequences on MRI in pre and post treatment tumors and correlate it with necrosis and survival
Outcome measures
| Measure |
Phase I: Ascorbate 75 mg IV Infusion
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.
|
|---|---|---|
|
Evaluate Diffusion Weighted Imaging Sequences
|
0 Participants
|
0 Participants
|
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 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
General disorders and administration site conditions
Fever
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
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 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
36.8%
7/19 • Number of events 10 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
21.1%
4/19 • Number of events 4 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
21.1%
4/19 • Number of events 5 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Rectal pain
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Jejunal hemorrhage
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
47.4%
9/19 • Number of events 11 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
General disorders and administration site conditions
Edema limbs
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
26.3%
5/19 • Number of events 6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
General disorders and administration site conditions
Fatigue
|
50.0%
3/6 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
26.3%
5/19 • Number of events 5 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
General disorders and administration site conditions
Fever
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 4 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
15.8%
3/19 • Number of events 5 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
General disorders and administration site conditions
Pain
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Infections and infestations
Thrush
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
33.3%
2/6 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
15.8%
3/19 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Investigations - Other, specify
|
50.0%
3/6 • Number of events 4 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
42.1%
8/19 • Number of events 26 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
4/6 • Number of events 4 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
36.8%
7/19 • Number of events 14 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
15.8%
3/19 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
Weight loss
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 4 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
26.3%
5/19 • Number of events 5 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
31.6%
6/19 • Number of events 9 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
26.3%
5/19 • Number of events 10 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
31.6%
6/19 • Number of events 9 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
15.8%
3/19 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/6 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
0.00%
0/19 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 2 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
5.3%
1/19 • Number of events 1 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
|
Vascular disorders
Hypertension
|
50.0%
3/6 • Number of events 8 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
10.5%
2/19 • Number of events 3 • Adverse events (AE) were collected after signing of Informed Consent Form and continued through the 30-day follow up period after treatment is discontinued, up to 12 weeks. Deaths (overall survival) was assessed for up to 2 years following the initiation of treatment.
|
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