Trial Outcomes & Findings for Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia (NCT NCT03318016)
NCT ID: NCT03318016
Last Updated: 2024-08-01
Results Overview
Number of Participants that were treated in each Cohort in attempt to establish Maximally Tolerated Dose (MTD) of cyclophosphamide with ATO is defined as the highest dose level of 1000 mg/m2. MTD is established when at least 6 participants within a Cohort have responded without toxicity. The trial is organized in a standard, phase I, 3+3 design. The first 3 subjects will be assigned to cohort 1. Per standard trial design, if there are 0/3 dose-limiting toxicities (DLT) in this cohort, the next three subjects will be assigned to cohort 2. This will continue until MTD is established.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
26 months
Results posted on
2024-08-01
Participant Flow
Participant milestones
| Measure |
Cohort -1
ATO at a fixed dose of 01.15 mg/kg/d IV followed by Cyclophosphamide 500mg/m2 on day 4 as a single IV dose along with hydration for a maximum of 6 doses
|
Cohort 1
ATO at a fixed dose of 01.15 mg/kg/d IV followed by Cyclophosphamide 1000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \> 1000 mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 2
ATO at a fixed dose of 01.15 mg/kg/d IV followed by Cyclophosphamide 2000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \> 1000 mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 3
ATO at a fixed dose of 01.15 mg/kg/d IV followed by Cyclophosphamide 3000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \> 1000 mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 4
ATO at a fixed dose of 01.15 mg/kg/d IV followed by Cyclophosphamide 4000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \> 1000 mg/m2 Cy) and hydration for a maximum of 6 doses
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
3
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
3
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Cohort -1
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 500 mg/m2 on day 4 as a single IV dose along with hydration for a maximum of 6 doses
|
Cohort 1
n=3 Participants
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 1000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 2
n=2 Participants
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 2000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 3
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 3000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 4
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 4000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
—
|
5 Participants
n=8 Participants
|
|
Age, Continuous
|
—
|
72 years
n=7 Participants
|
68 years
n=5 Participants
|
—
|
—
|
78 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
—
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
—
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
—
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
—
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
—
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
—
|
—
|
5 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 26 monthsPopulation: Patients With Relapsed/Refractory Acute Myeloid Leukemia
Number of Participants that were treated in each Cohort in attempt to establish Maximally Tolerated Dose (MTD) of cyclophosphamide with ATO is defined as the highest dose level of 1000 mg/m2. MTD is established when at least 6 participants within a Cohort have responded without toxicity. The trial is organized in a standard, phase I, 3+3 design. The first 3 subjects will be assigned to cohort 1. Per standard trial design, if there are 0/3 dose-limiting toxicities (DLT) in this cohort, the next three subjects will be assigned to cohort 2. This will continue until MTD is established.
Outcome measures
| Measure |
Cohort -1
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 500 mg/m2 on day 4 as a single IV dose along with hydration for a maximum of 6 doses.
|
Cohort 1
n=3 Participants
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 1000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \>1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 2
n=2 Participants
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 2000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \>1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 3
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 3000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \>1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 4
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 4000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \>1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
|---|---|---|---|---|---|
|
Number of Participants That Reached Maximally Tolerated Dose (MTD) of Cyclophosphamide and ATO
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 26 monthsPopulation: Subjects provided both ATO and Cyclophosphamide
ORR defined by complete remission/complete remission with incomplete recovery of blood counts (CR/CRi), morphologic leukemia free state (MLFS) and partial responses (PR)
Outcome measures
| Measure |
Cohort -1
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 500 mg/m2 on day 4 as a single IV dose along with hydration for a maximum of 6 doses.
|
Cohort 1
n=3 Participants
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 1000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \>1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 2
n=2 Participants
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 2000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \>1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 3
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 3000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \>1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 4
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 4000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving \>1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR) Using ATO and Cyclophosphamide
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
Adverse Events
Cohort -1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort -1
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 500 mg/m2 on day 4 as a single IV dose along with hydration for a maximum of 6 doses.
|
Cohort 1
n=3 participants at risk
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 1000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 2
n=2 participants at risk
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 2000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 3
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 3000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 4
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 4000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
Other adverse events
| Measure |
Cohort -1
Cyclophosphamide: ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 500 mg/m2 on day 4 as a single IV dose along with hydration for a maximum of 6 doses.
|
Cohort 1
n=3 participants at risk
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 1000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 2
n=2 participants at risk
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 2000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 3
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 3000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
Cohort 4
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide 4000 mg/m2 on day 4 as a single IV dose along with Mesna (in subjects receiving ≥1000mg/m2 Cy) and hydration for a maximum of 6 doses
|
|---|---|---|---|---|---|
|
General disorders
Activity Change
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/3 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
General disorders
Anorexia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
General disorders
Appetite Change
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
chills
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/3 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Psychiatric disorders
Depression
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/3 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Edema
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
66.7%
2/3 • Number of events 2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Renal and urinary disorders
Creatinine Increase
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/3 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Skin and subcutaneous tissue disorders
epistaxis
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
66.7%
2/3 • Number of events 2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
General disorders
Fatigue
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
General disorders
Fever
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
66.7%
2/3 • Number of events 2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Hypotension
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/3 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Metabolism and nutrition disorders
Constipation
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/3 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Hypomagnesia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Nervous system disorders
Sensory neuropathy
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/3 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
50.0%
1/2 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
General disorders
Lip ulcer
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Pallor
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Cardiac disorders
prolonged QTc
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Skin and subcutaneous tissue disorders
rash
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Skin and subcutaneous tissue disorders
skin tear
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Metabolism and nutrition disorders
tarry stool
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
General disorders
throat irritation
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
|
Blood and lymphatic system disorders
thrombophlebitis
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
33.3%
1/3 • Number of events 1 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
0.00%
0/2 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
—
0/0 • 26 months
Some cohorts did not accrue any subjects. Therefor, the number of Serious Adverse Events, All-Cause Mortality and Other Adverse Events is zero.
|
Additional Information
Daniel Pollyea, MD Associate Professor
University of Colorado Hospital
Phone: 720-848-8084
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place