Trial Outcomes & Findings for Gemcitabine Plus Ascorbate for Sarcoma in Adults (NCT NCT03468075)
NCT ID: NCT03468075
Last Updated: 2020-12-10
Results Overview
From first day of treatment to documented disease progression as described by RECIST 1.1 criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Every 2 months for first 6 months, then every 3 months up to 2 years post treatment
Results posted on
2020-12-10
Participant Flow
Participant milestones
| Measure |
Gemcitabine + High-Dose Ascorbate
Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.
Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine Plus Ascorbate for Sarcoma in Adults
Baseline characteristics by cohort
| Measure |
Gemcitabine + High-Dose Ascorbate
n=10 Participants
Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.
Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 2 months for first 6 months, then every 3 months up to 2 years post treatmentFrom first day of treatment to documented disease progression as described by RECIST 1.1 criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.
Outcome measures
| Measure |
Gemcitabine + High-Dose Ascorbate
n=10 Participants
Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.
Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate
|
|---|---|
|
Tumor Response
PD
|
8 Participants
|
|
Tumor Response
SD
|
1 Participants
|
|
Tumor Response
PR
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 2 months for first 6 months, then every 3 months up to 2 years post treatmentTime from start of therapy (day 1, cycle 1) to documented disease progression or death due to any cause. Progression will be defined using the RECIST 1.1 guidelines. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.
Outcome measures
| Measure |
Gemcitabine + High-Dose Ascorbate
n=10 Participants
Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.
Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate
|
|---|---|
|
Progression Free Survival
2 months
|
7 Participants
|
|
Progression Free Survival
3 months
|
1 Participants
|
|
Progression Free Survival
6 months
|
1 Participants
|
|
Progression Free Survival
9 months
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 2 months for first 6 months, then every 3 months up to 2 years post treatmentTime from start of therapy (day 1, cycle 1) to death.
Outcome measures
| Measure |
Gemcitabine + High-Dose Ascorbate
n=10 Participants
Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.
Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate
|
|---|---|
|
Overall Survival
Alive
|
5 Participants
|
|
Overall Survival
Dead
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of study treatmentCategorize and quantify adverse events from start of therapy (day 1, cycle 1) to end of study per (CTCAE) version 4.03.
Outcome measures
| Measure |
Gemcitabine + High-Dose Ascorbate
n=10 Participants
Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.
Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate
|
|---|---|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Blood and lymphatic system disorders
|
4 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Gastrointestinal disorders
|
7 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Infections and infestations
|
1 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Investigations
|
43 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Metabolism and nutrition disorders
|
2 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Musculoskeletal and connective tissue disorders
|
1 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Psychiatric disorders
|
1 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Renal and urinary disorders
|
1 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Respiratory, thoracic and mediastinal disorders
|
11 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Skin and subcutaneous tissue disorders
|
3 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
Vascular disorders
|
2 adverse events
|
|
Incidence of Adverse Events (AE) Per CTCAE 4.03
General disorders and administration site conditions
|
7 adverse events
|
Adverse Events
Gemcitabine + High-Dose Ascorbate
Serious events: 2 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Gemcitabine + High-Dose Ascorbate
n=10 participants at risk
Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.
Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
Other adverse events
| Measure |
Gemcitabine + High-Dose Ascorbate
n=10 participants at risk
Subjects will receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator.
Ascorbate: Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
Gemcitabine: Administered on Days 1, 8 and 15, after the infusion of ascorbate
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Number of events 4 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
General disorders
Edema limbs
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
General disorders
Fever
|
20.0%
2/10 • Number of events 3 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • Number of events 2 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Investigations
GGT increased
|
10.0%
1/10 • Number of events 2 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Investigations
Neutrophil count decreased
|
60.0%
6/10 • Number of events 9 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Investigations
Platelet count decreased
|
60.0%
6/10 • Number of events 26 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Investigations
Weight loss
|
10.0%
1/10 • Number of events 2 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Number of events 3 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
30.0%
3/10 • Number of events 4 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • Number of events 2 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.0%
1/10 • Number of events 1 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 2 • AEs were collected up to 30 days after completion of study treatment, up to 7 months
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected and recorded and followed as appropriate. Adverse events were followed for 30 days post last dose of drug.
|
Additional Information
Clinical Assistant Professor
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