Trial Outcomes & Findings for Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide (NCT NCT01059071)
NCT ID: NCT01059071
Last Updated: 2024-08-06
Results Overview
To determine the safety, tolerability and maximum tolerated dose (MTD) of DFMO as a single agent and in combination with etoposide in pediatric and young adult patients with refractory or recurrent neuroblastoma
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
length of study plus 30 days
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
Dose Level 1: 500 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 2: 750 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 3:1000 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 4:1500 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
3
|
9
|
|
Overall Study
COMPLETED
|
2
|
1
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
2
|
6
|
Reasons for withdrawal
| Measure |
Dose Level 1: 500 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 2: 750 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 3:1000 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 4:1500 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
4
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide
Baseline characteristics by cohort
| Measure |
DFMO and Etoposide
n=21 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|
|
Age, Continuous
|
8.75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: length of study plus 30 daysPopulation: Received at least one dose of DFMO
To determine the safety, tolerability and maximum tolerated dose (MTD) of DFMO as a single agent and in combination with etoposide in pediatric and young adult patients with refractory or recurrent neuroblastoma
Outcome measures
| Measure |
Dose Level 3:1000 mg/m2 PO BID
n=3 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 1: 500 mg/m2 PO BID
n=4 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 2: 750 mg/m2 PO BID
n=5 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 4:1500 mg/m2 PO BID
n=9 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
0 participants
|
2 participants
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Dose Level 3:1000 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 1: 500 mg/m2 PO BID
n=18 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 2: 750 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 4:1500 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
—
|
85 Days
Interval 62.0 to 418.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Dose Level 3:1000 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 1: 500 mg/m2 PO BID
n=18 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 2: 750 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 4:1500 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|---|---|---|
|
Number of Patients With an Overall Response Rate (ORR) of PR or CR
|
—
|
4 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hoursPopulation: Cohort at max dose of 1500mg/m2 BID
Outcome measures
| Measure |
Dose Level 3:1000 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 1: 500 mg/m2 PO BID
n=9 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 2: 750 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 4:1500 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|---|---|---|
|
Tmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.
|
—
|
2.88 hours
Standard Deviation 1.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hoursPopulation: Cohort at max dose of 1500mg/m2 BID
Outcome measures
| Measure |
Dose Level 3:1000 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 1: 500 mg/m2 PO BID
n=9 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 2: 750 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 4:1500 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|---|---|---|
|
Cmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.
|
—
|
28.89 mcg/ml
Standard Deviation 14.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hoursPopulation: Cohort at max dose of 1500mg/m2 BID
Outcome measures
| Measure |
Dose Level 3:1000 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 3:1000 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 1: 500 mg/m2 PO BID
n=9 Participants
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 2: 750 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 2: 750 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
Dose Level 4:1500 mg/m2 PO BID
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|---|---|---|
|
AUC of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.
|
—
|
108.38 (mcg/ml) * hr
Standard Deviation 53.23
|
—
|
—
|
Adverse Events
DFMO and Etoposide
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DFMO and Etoposide
n=21 participants at risk
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression of Disease resulting in death
|
9.5%
2/21 • Number of events 2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
Other adverse events
| Measure |
DFMO and Etoposide
n=21 participants at risk
DFMO: Escalating doses of DFMO in a 3 +3 cohort design.
DFMO at current cohort Dose Level orally each day for 21 day cycles
Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID
Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
19.0%
4/21 • Number of events 8 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Blood and lymphatic system disorders
Neutorpenia
|
23.8%
5/21 • Number of events 9 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
1/21 • Number of events 5 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Hepatobiliary disorders
ALT elevation
|
9.5%
2/21 • Number of events 2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
General disorders
Anorexia
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Hepatobiliary disorders
AST elevation
|
14.3%
3/21 • Number of events 3 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Eye disorders
Conjunctivitis
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Number of events 2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Blood and lymphatic system disorders
GGT elevation
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Infection, sinus
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Gastrointestinal disorders
Mouth pain
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Nervous system disorders
Neuropathy
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
General disorders
Pain
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
General disorders
Sleep disturbance
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Renal and urinary disorders
urinary retention
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
|
Gastrointestinal disorders
vomiting
|
4.8%
1/21 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60