Trial Outcomes & Findings for MIBG With Dinutuximab +/- Vorinostat (NCT NCT03332667)
NCT ID: NCT03332667
Last Updated: 2025-04-16
Results Overview
Proportion of patients with Course 1 DLT in Cohort A
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
All toxicities from enrollment until completion of course 1 (Day 56)
Results posted on
2025-04-16
Participant Flow
Participant milestones
| Measure |
Cohort A DL1
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort B DL4
Vorinostat will be given on days 0-13 at 180mg/m2/dose. Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
20
|
14
|
|
Overall Study
COMPLETED
|
1
|
2
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
14
|
3
|
Reasons for withdrawal
| Measure |
Cohort A DL1
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort B DL4
Vorinostat will be given on days 0-13 at 180mg/m2/dose. Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
5
|
1
|
|
Overall Study
Disease Progression or Relapse
|
2
|
1
|
3
|
0
|
|
Overall Study
Initiation onto Another Anti-Cancer Therapy
|
1
|
1
|
3
|
1
|
|
Overall Study
No Treatment Received
|
0
|
0
|
1
|
0
|
Baseline Characteristics
MIBG With Dinutuximab +/- Vorinostat
Baseline characteristics by cohort
| Measure |
Cohort A DL1
n=6 Participants
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
n=5 Participants
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
n=20 Participants
Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort B DL4
n=14 Participants
Vorinostat will be given on days 0-13 at 180mg/m2/dose. Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: All toxicities from enrollment until completion of course 1 (Day 56)Proportion of patients with Course 1 DLT in Cohort A
Outcome measures
| Measure |
Cohort A DL1
n=4 Participants
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
n=4 Participants
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
n=11 Participants
Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|
|
MTD/RP2D Determination Cohort A
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: All toxicities from enrollment until completion of course 1 (Day 56)Proportion of patients with Course 1 DLT in Cohort B
Outcome measures
| Measure |
Cohort A DL1
n=12 Participants
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|
|
MTD/RP2D Determination Cohort B
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, up to 5 monthsProportion of patients with any grade 3 or greater non-hematological toxicities in Cohort A
Outcome measures
| Measure |
Cohort A DL1
n=6 Participants
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
n=5 Participants
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
n=19 Participants
Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|
|
Describe Non-Hematological Toxicities Cohort A
|
5 Participants
|
3 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, up to 5 monthsProportion of patients with any grade 3 or greater non-hematological toxicities in Cohort B
Outcome measures
| Measure |
Cohort A DL1
n=14 Participants
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|
|
Describe Non Hematological Toxicities Cohort B
|
12 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of protocol therapy through 30 days following end of protocol therapy, up to 5 monthsProportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in Cohort A
Outcome measures
| Measure |
Cohort A DL1
n=6 Participants
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
n=5 Participants
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
n=15 Participants
Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|
|
Overall Response Cohort A
|
2 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Day 1 of protocol therapy through 30 days following end of protocol therapy, up to 5 monthsProportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in Cohort B
Outcome measures
| Measure |
Cohort A DL1
n=12 Participants
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|
|
Overall Response Cohort B
|
5 Participants
|
—
|
—
|
Adverse Events
Cohort A DL1
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Cohort A DL2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Cohort A DL3
Serious events: 6 serious events
Other events: 19 other events
Deaths: 12 deaths
Cohort B DL4
Serious events: 8 serious events
Other events: 14 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort A DL1
n=6 participants at risk
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
n=5 participants at risk
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
n=20 participants at risk
Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort B DL4
n=14 participants at risk
Vorinostat will be given on days 0-13 at 180mg/m2/dose. Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Fever
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
28.6%
4/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Spinal cord compression
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
Other adverse events
| Measure |
Cohort A DL1
n=6 participants at risk
Patients will receive 131I-MIBG on day 1 at 12mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL2
n=5 participants at risk
Patients will receive 131I-MIBG on day 1 at 15mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort A DL3
n=20 participants at risk
Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
Cohort B DL4
n=14 participants at risk
Vorinostat will be given on days 0-13 at 180mg/m2/dose. Patients will receive 131I-MIBG on day 1 at 18mCI/kg/dose. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy at 17mg/m2/dose. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
6/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
80.0%
4/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
80.0%
16/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
85.7%
12/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
BLEEDING
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
4/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
21.4%
3/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Methemoglobinemia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Cardiac disorders
GALLOP RHYTHM
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
28.6%
4/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Cardiac disorders
Sinus tachycardia
|
83.3%
5/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
45.0%
9/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
7/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Ear and labyrinth disorders
Ear Pain
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
21.4%
3/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Eye disorders
EYE DISCHARGE
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Eye disorders
EYE ITCHINESS
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Eye disorders
Periorbital edema
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Eye disorders
REDNESS
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
15.0%
3/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
42.9%
6/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
4/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
30.0%
6/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
42.9%
6/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
4/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
64.3%
9/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
4/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
70.0%
14/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
85.7%
12/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
ORAL THRUSH
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
100.0%
5/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
10/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
85.7%
12/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Disease Progression
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Edema face
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Edema limbs
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Facial pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
35.7%
5/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Fatigue
|
50.0%
3/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
25.0%
5/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
42.9%
6/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Fever
|
50.0%
3/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
60.0%
3/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
8/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
78.6%
11/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Flu like symptoms
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Generalized edema
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Localized edema
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
General disorders
Pain
|
66.7%
4/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
60.0%
3/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
10/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
7/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
15.0%
3/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Conjunctivities
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
21.4%
3/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Otitis media
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Thrush
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
25.0%
5/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
15.0%
3/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
10/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
78.6%
11/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
28.6%
4/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
60.0%
3/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
55.0%
11/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
78.6%
11/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
42.9%
6/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
15.0%
3/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
GGT increased
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Hemoglobin increased
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
INR increased
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
6/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
100.0%
5/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
80.0%
16/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
100.0%
14/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Neutrophil count decreased
|
83.3%
5/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
60.0%
3/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
75.0%
15/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
92.9%
13/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Platelet count decreased
|
83.3%
5/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
100.0%
5/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
80.0%
16/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
92.9%
13/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Weight gain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
Weight loss
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
4/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
35.7%
5/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Investigations
White blood cell decreased
|
100.0%
6/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
100.0%
5/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
90.0%
18/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
92.9%
13/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
10/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
35.7%
5/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
3/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
30.0%
6/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
64.3%
9/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
21.4%
3/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
4/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
28.6%
4/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
35.7%
5/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
83.3%
5/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
100.0%
5/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
65.0%
13/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
85.7%
12/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
83.3%
5/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
80.0%
4/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
10/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
85.7%
12/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
83.3%
5/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
80.0%
4/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
30.0%
6/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
78.6%
11/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
60.0%
3/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
4/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
42.9%
6/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
8/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
71.4%
10/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
60.0%
3/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
10/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
64.3%
9/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
15.0%
3/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
JAW PAIN
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
28.6%
4/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
28.6%
4/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Spasticity
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Stroke
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
25.0%
5/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
21.4%
3/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
21.4%
3/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Bladder spasm
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
FOLEY PAIN
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
28.6%
4/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
30.0%
6/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
7/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
28.6%
4/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
21.4%
3/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
RHINOVIRUS OR ENTEROVIRUS
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
21.4%
3/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
DIAPER RASH
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
15.0%
3/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
IRRITATION AT PORT SITE
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
PERINEUM REDNESS & ITCHSING
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
30.0%
6/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
42.9%
6/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
REDNESS FROM RUBBING
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
7.1%
1/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
UNSPECIFIED NON-PRURITIC RASH
|
16.7%
1/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
10.0%
2/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
14.3%
2/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
20.0%
1/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
21.4%
3/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Hypertension
|
83.3%
5/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
25.0%
5/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
28.6%
4/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Hypotension
|
33.3%
2/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
40.0%
2/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
35.0%
7/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
50.0%
7/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/5 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
5.0%
1/20 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
0.00%
0/14 • All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months
Adverse events were collected through regular investigator assessment and regular laboratory testing.
|
Additional Information
NANT Medical Director
New Advances in Neuroblastoma Therapy
Phone: 3233615687
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place