Trial Outcomes & Findings for Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101) (NCT NCT02773732)
NCT ID: NCT02773732
Last Updated: 2022-08-05
Results Overview
Establish the maximum tolerated dose (MTD) of oral ciprofloxacin when given in combination with a fixed dose of oral Etoposide for the treatment of resistant AML.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
1 month
Results posted on
2022-08-05
Participant Flow
Participant milestones
| Measure |
Ciprofloxacin Dose Level 0
750 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Ciprofloxacin Dose Level +1
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
|---|---|---|
|
Ciprofloxacin Dose Level 0
STARTED
|
3
|
0
|
|
Ciprofloxacin Dose Level 0
COMPLETED
|
3
|
0
|
|
Ciprofloxacin Dose Level 0
NOT COMPLETED
|
0
|
0
|
|
Ciprofloxacin Dose Level +1
STARTED
|
0
|
8
|
|
Ciprofloxacin Dose Level +1
COMPLETED
|
0
|
8
|
|
Ciprofloxacin Dose Level +1
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101)
Baseline characteristics by cohort
| Measure |
Ciprofloxacin Dose Level 0
n=3 Participants
750 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Ciprofloxacin Dose Level +1
n=8 Participants
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
68.67 years
n=99 Participants
|
61.75 years
n=107 Participants
|
63.64 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
8 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 2 subjects were not evaluable for this outcome measure.
Establish the maximum tolerated dose (MTD) of oral ciprofloxacin when given in combination with a fixed dose of oral Etoposide for the treatment of resistant AML.
Outcome measures
| Measure |
Ciprofloxacin and Etoposide
n=9 Participants
Ciprofloxacin: Ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Dose Level 0 Ciprofloxacin 750 mg Dose Level +1 Ciprofloxacin 1000 mg Dose Level -1 Ciprofloxacin 500 mg
Etoposide: Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Ciprofloxacin Dose Level +1
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle
|
|---|---|---|
|
Maximum Tolerated Dose
|
1000 milligrams
|
—
|
PRIMARY outcome
Timeframe: 0 monthsPopulation: No participants were analyzed for this outcome measure because the study did not proceed to phase II.
Determine the rate of complete remission (CR) following treatment with the MTD of oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 111 daysPopulation: Only 1 participant in the ciprofloxacin Dose Level +1 cohort had a response to measure response duration.
Measure the response duration following treatment with oral ciprofloxacin in combination with oral etoposide for the treatment of resistant AML.
Outcome measures
| Measure |
Ciprofloxacin and Etoposide
n=1 Participants
Ciprofloxacin: Ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Dose Level 0 Ciprofloxacin 750 mg Dose Level +1 Ciprofloxacin 1000 mg Dose Level -1 Ciprofloxacin 500 mg
Etoposide: Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Ciprofloxacin Dose Level +1
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle
|
|---|---|---|
|
Response Duration
|
111 days
|
—
|
SECONDARY outcome
Timeframe: 317 daysMeasure progression-free survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML.
Outcome measures
| Measure |
Ciprofloxacin and Etoposide
n=3 Participants
Ciprofloxacin: Ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Dose Level 0 Ciprofloxacin 750 mg Dose Level +1 Ciprofloxacin 1000 mg Dose Level -1 Ciprofloxacin 500 mg
Etoposide: Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Ciprofloxacin Dose Level +1
n=8 Participants
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle
|
|---|---|---|
|
Progression-free Survival
|
56 days
Interval 25.0 to 115.0
|
92.25 days
Interval 26.0 to 317.0
|
SECONDARY outcome
Timeframe: 317 daysPopulation: 1 subject was still alive at the time protocol follow-up was discontinued, so they are not included in the analysis for this outcome measure.
Measure overall survival following treatment with oral ciprofloxacin in combination with oral Etoposide for the treatment of resistant AML.
Outcome measures
| Measure |
Ciprofloxacin and Etoposide
n=3 Participants
Ciprofloxacin: Ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Dose Level 0 Ciprofloxacin 750 mg Dose Level +1 Ciprofloxacin 1000 mg Dose Level -1 Ciprofloxacin 500 mg
Etoposide: Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Ciprofloxacin Dose Level +1
n=7 Participants
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle
|
|---|---|---|
|
Overall Survival
|
140.67 days
Interval 25.0 to 282.0
|
109.29 days
Interval 43.0 to 317.0
|
SECONDARY outcome
Timeframe: 93 daysEstimate the rate of Grade ≥ 3 adverse events following treatment with oral ciprofloxacin and oral etoposide at the MTD.
Outcome measures
| Measure |
Ciprofloxacin and Etoposide
n=3 Participants
Ciprofloxacin: Ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Dose Level 0 Ciprofloxacin 750 mg Dose Level +1 Ciprofloxacin 1000 mg Dose Level -1 Ciprofloxacin 500 mg
Etoposide: Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Ciprofloxacin Dose Level +1
n=8 Participants
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle
|
|---|---|---|
|
Percentage of Grade ≥ 3 Adverse Events
|
20 percentage of reported adverse events
|
28.45 percentage of reported adverse events
|
Adverse Events
Ciprofloxacin Dose Level 0
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Ciprofloxacin Dose Level +1
Serious events: 4 serious events
Other events: 7 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Ciprofloxacin Dose Level 0
n=3 participants at risk
750 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Ciprofloxacin Dose Level +1
n=8 participants at risk
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Fever
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Cardiac disorders
Cardiac disorders - other, specify
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
37.5%
3/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - other, specify
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
Other adverse events
| Measure |
Ciprofloxacin Dose Level 0
n=3 participants at risk
750 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
Ciprofloxacin Dose Level +1
n=8 participants at risk
1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.
Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
62.5%
5/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Cardiac disorders
Cardiac disorders - other, specify
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Chills
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Psychiatric disorders
Confusion
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
50.0%
4/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Dehydration
|
66.7%
2/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
37.5%
3/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Nervous system disorders
Dizziness
|
100.0%
3/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Edema face
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Edema limbs
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
37.5%
3/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Eye disorders
Eye pain
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Fatigue
|
66.7%
2/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
50.0%
4/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - other, specify
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
66.7%
2/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
50.0%
4/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
37.5%
3/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
37.5%
3/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
50.0%
4/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
37.5%
3/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
62.5%
5/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Vascular disorders
Hypotension
|
66.7%
2/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
37.5%
3/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
50.0%
4/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
37.5%
3/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
General disorders
Pain
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Eye disorders
Photophobia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
62.5%
5/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Renal and urinary disorders
Urinary frequency
|
66.7%
2/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
0.00%
0/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
25.0%
2/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
12.5%
1/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
37.5%
3/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
62.5%
5/8 • At minimum, adverse event data were collected at screening, every 7 days during study treatment and at 28 days after the last dose of study treatment. Adverse event data were collected for a maximum of 93 days for all participants. All-cause mortality data was collected over a maximum of 317 days for all participants.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, every 7 days during study treatment, and at 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place