Trial Outcomes & Findings for Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults (NCT NCT02101736)
NCT ID: NCT02101736
Last Updated: 2023-05-24
Results Overview
We will estimate the objective response rate (ORR) as defined by 20% volumetric MRI response of the target lesion to cabozantinib at 12 months in adolescents and adults with Neurofibromatosis type 1 (NF1) plexiform neurofibromas by volumetric MRI imaging.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
baseline to 12 Months
Results posted on
2023-05-24
Participant Flow
Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. However, for Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles are considered treatment failure and taken off study was eliminated.
Participant milestones
| Measure |
Cohort A
Cohort A (≥ 16 years - closed to accrual): Starting cabozantinib of 40 mg daily by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 60 mg based on dose tolerability. Subjects who do not tolerate 40 mg will dose reduce to 20 mg. Doses will be capped at 60 mg.
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. However, for Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study.
|
Cohort B
Cohort B (3 - 15 years). The starting cabozantinib dose is 30 mg/m2/day by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 40 mg/m2/day based on dose tolerability. Subjects who do not tolerate 30 mg/m2/day will dose reduce to 23 mg/m2/day. Doses will be capped at 60 mg/day max daily dose.
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles are considered treatment failure and taken off study was eliminated.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Cohort A
Cohort A (≥ 16 years - closed to accrual): Starting cabozantinib of 40 mg daily by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 60 mg based on dose tolerability. Subjects who do not tolerate 40 mg will dose reduce to 20 mg. Doses will be capped at 60 mg.
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. However, for Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study.
|
Cohort B
Cohort B (3 - 15 years). The starting cabozantinib dose is 30 mg/m2/day by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 40 mg/m2/day based on dose tolerability. Subjects who do not tolerate 30 mg/m2/day will dose reduce to 23 mg/m2/day. Doses will be capped at 60 mg/day max daily dose.
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles are considered treatment failure and taken off study was eliminated.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
Baseline characteristics by cohort
| Measure |
Cohort A
n=23 Participants
Cohort A (≥ 16 years - closed to accrual): Starting cabozantinib of 40 mg daily by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 60 mg based on dose tolerability. Subjects who do not tolerate 40 mg will dose reduce to 20 mg. Doses will be capped at 60 mg.
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study.
|
Cohort B
n=22 Participants
Cohort B (3 - 15 years). The starting cabozantinib dose is 30 mg/m2/day by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 40 mg/m2/day based on dose tolerability. Subjects who do not tolerate 30 mg/m2/day will dose reduce to 23 mg/m2/day. Doses will be capped at 60 mg/day max daily dose
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles are considered treatment failure and taken off study was eliminated.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.3 years
STANDARD_DEVIATION 5.49 • n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
10 years
STANDARD_DEVIATION 4.28 • n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
16.65 years
STANDARD_DEVIATION 4.89 • n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Sex: Female, Male
Female
|
9 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
11 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
20 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Sex: Female, Male
Male
|
14 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
11 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
25 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
3 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
3 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
19 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
41 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
0 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
1 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Race (NIH/OMB)
Overall Study · American Indian or Alaska Native
|
0 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
0 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
0 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Race (NIH/OMB)
Overall Study · Asian
|
2 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
1 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
3 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Race (NIH/OMB)
Overall Study · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
0 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
1 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Race (NIH/OMB)
Overall Study · Black or African American
|
1 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
3 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
4 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Race (NIH/OMB)
Overall Study · White
|
17 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
16 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
33 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Race (NIH/OMB)
Overall Study · More than one race
|
0 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
0 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
0 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Race (NIH/OMB)
Overall Study · Unknown or Not Reported
|
2 Participants
n=23 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
2 Participants
n=22 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
4 Participants
n=45 Participants • There are two cohorts. Cohort A had 23 subjects at baseline and Cohort B had 22 subjects at baseline. The overall total was 45 subjects at baseline.
|
|
Volumetric Response
|
556.6 mm^3
n=19 Participants • There are two cohorts with different numbers of evaluable subjects in each.
|
355.1 mm^3
n=21 Participants • There are two cohorts with different numbers of evaluable subjects in each.
|
455.9 mm^3
n=40 Participants • There are two cohorts with different numbers of evaluable subjects in each.
|
PRIMARY outcome
Timeframe: baseline to 12 MonthsPopulation: There were a total of 19 evaluable subjects from Cohort A and 21 for Cohort B.
We will estimate the objective response rate (ORR) as defined by 20% volumetric MRI response of the target lesion to cabozantinib at 12 months in adolescents and adults with Neurofibromatosis type 1 (NF1) plexiform neurofibromas by volumetric MRI imaging.
Outcome measures
| Measure |
Cohort A
n=19 Participants
Cohort A (≥ 16 years - closed to accrual): Starting cabozantinib of 40 mg daily by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 60 mg based on dose tolerability. Subjects who do not tolerate 40 mg will dose reduce to 20 mg. Doses will be capped at 60 mg.
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. For both cohorts, subjects will receive cabozantinib orally in continuous cycles. Each cycle is 28 days. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with radiographic response (20% or greater reduction in tumor volume) at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study.
|
Cohort B
n=21 Participants
Cohort B (3 - 15 years). The starting cabozantinib dose is 30 mg/m2/day by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 40 mg/m2/day based on dose tolerability. Subjects who do not tolerate 30 mg/m2/day will dose reduce to 23 mg/m2/day. Doses will be capped at 60 mg/day max daily dose
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. For both cohorts, subjects will receive cabozantinib orally in continuous cycles. Each cycle is 28 days. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with radiographic response (20% or greater reduction in tumor volume) at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles was eliminated.
|
|---|---|---|
|
The Change in Tumor Size Based on Radiographic Assessment
|
-15.7 mm^3
Interval -38.0 to 2.8
|
-4.1 mm^3
Interval -25.8 to 12.5
|
SECONDARY outcome
Timeframe: baseline to 24 monthsThis is the number of participants with one or more adverse events.
Outcome measures
| Measure |
Cohort A
n=23 Participants
Cohort A (≥ 16 years - closed to accrual): Starting cabozantinib of 40 mg daily by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 60 mg based on dose tolerability. Subjects who do not tolerate 40 mg will dose reduce to 20 mg. Doses will be capped at 60 mg.
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. For both cohorts, subjects will receive cabozantinib orally in continuous cycles. Each cycle is 28 days. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with radiographic response (20% or greater reduction in tumor volume) at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study.
|
Cohort B
n=22 Participants
Cohort B (3 - 15 years). The starting cabozantinib dose is 30 mg/m2/day by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 40 mg/m2/day based on dose tolerability. Subjects who do not tolerate 30 mg/m2/day will dose reduce to 23 mg/m2/day. Doses will be capped at 60 mg/day max daily dose
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. For both cohorts, subjects will receive cabozantinib orally in continuous cycles. Each cycle is 28 days. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with radiographic response (20% or greater reduction in tumor volume) at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles was eliminated.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
20 Participants
|
21 Participants
|
Adverse Events
Cohort A
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Cohort B
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A
n=23 participants at risk
Cohort A (≥ 16 years - closed to accrual): Starting cabozantinib of 40 mg daily by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 60 mg based on dose tolerability. Subjects who do not tolerate 40 mg will dose reduce to 20 mg. Doses will be capped at 60 mg.
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study.
|
Cohort B
n=22 participants at risk
Cohort B (3 - 15 years). The starting cabozantinib dose is 30 mg/m2/day by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 40 mg/m2/day based on dose tolerability. Subjects who do not tolerate 30 mg/m2/day will dose reduce to 23 mg/m2/day. Doses will be capped at 60 mg/day max daily dose
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles are considered treatment failure and taken off study was eliminated.
|
|---|---|---|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
VOMITING
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
SKIN INFECTION
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
ABSCESS
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
JOINT RANGE OF MOTION DECREASED
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
Other adverse events
| Measure |
Cohort A
n=23 participants at risk
Cohort A (≥ 16 years - closed to accrual): Starting cabozantinib of 40 mg daily by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 60 mg based on dose tolerability. Subjects who do not tolerate 40 mg will dose reduce to 20 mg. Doses will be capped at 60 mg.
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study.
|
Cohort B
n=22 participants at risk
Cohort B (3 - 15 years). The starting cabozantinib dose is 30 mg/m2/day by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 40 mg/m2/day based on dose tolerability. Subjects who do not tolerate 30 mg/m2/day will dose reduce to 23 mg/m2/day. Doses will be capped at 60 mg/day max daily dose
Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles are considered treatment failure and taken off study was eliminated.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Cardiac disorders
PALPITATIONS
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
8.7%
2/23 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Ear and labyrinth disorders
VERTIGO
|
8.7%
2/23 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
17.4%
4/23 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
95.5%
21/22 • Number of events 32 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Eye disorders
BLURRED VISION
|
39.1%
9/23 • Number of events 38 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
21.7%
5/23 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
27.3%
6/22 • Number of events 9 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
BLOATING
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
CONSTIPATION
|
17.4%
4/23 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
DIARRHEA
|
13.0%
3/23 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
72.7%
16/22 • Number of events 33 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
DRY MOUTH
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
8.7%
2/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
NAUSEA
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
40.9%
9/22 • Number of events 17 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
ORAL DYSESTHESIA
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
ORAL PAIN
|
8.7%
2/23 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
PANCREATITIS
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
VOMITING
|
8.7%
2/23 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
40.9%
9/22 • Number of events 20 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
General disorders
FATIGUE
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
50.0%
11/22 • Number of events 18 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
General disorders
PAIN
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
31.8%
7/22 • Number of events 15 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
13.0%
3/23 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
36.4%
8/22 • Number of events 11 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
General disorders
EDEMA LIMBS
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
General disorders
GAIT DISTURBANCE
|
73.9%
17/23 • Number of events 101 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
PARONYCHIA
|
13.0%
3/23 • Number of events 13 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Injury, poisoning and procedural complications
BRUISING
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
ABSOLUTE LYMPHOCYTE COUNT INCREASED
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
ABSOLUTE NEUTROPHIL COUNT DECREASED
|
17.4%
4/23 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
ABSOLUTE NEUTROPHIL COUNT INCREASED
|
56.5%
13/23 • Number of events 38 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
ALANINE AMINOTRANSFERASE DECREASED
|
13.0%
3/23 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
40.9%
9/22 • Number of events 12 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
40.9%
9/22 • Number of events 18 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
BILIRUBIN INCREASED
|
13.0%
3/23 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
BUN INCREASED
|
43.5%
10/23 • Number of events 55 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
HEMOGLOBIN INCREASED
|
4.3%
1/23 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
18.2%
4/22 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
LIPASE INCREASED
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
PLATELET COUNT DECREASE
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
22.7%
5/22 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
SERUM AMYLASE INCREASED
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
SKIN INFECTION
|
26.1%
6/23 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Endocrine disorders
THYROID STIMULATING HORMONE INCREASED
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
WEIGHT GAIN
|
17.4%
4/23 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
WEIGHT LOSS
|
78.3%
18/23 • Number of events 32 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
54.5%
12/22 • Number of events 21 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
WHITE BLOOD CELL INCREASED
|
13.0%
3/23 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
ANOREXIA
|
8.7%
2/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
40.9%
9/22 • Number of events 13 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
13.0%
3/23 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
17.4%
4/23 • Number of events 20 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
8.7%
2/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
18.2%
4/22 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
13.0%
3/23 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
8.7%
2/23 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
22.7%
5/22 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
18.2%
4/22 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOR PAIN
|
13.0%
3/23 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
DIZZINESS
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
DYSGEUSIA
|
26.1%
6/23 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
HEADACHE
|
43.5%
10/23 • Number of events 55 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
36.4%
8/22 • Number of events 9 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Psychiatric disorders
ANXIETY
|
4.3%
1/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Psychiatric disorders
INSOMNIA
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Renal and urinary disorders
HEMATURIA
|
26.1%
6/23 • Number of events 26 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Renal and urinary disorders
PROTEINURIA
|
13.0%
3/23 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
31.8%
7/22 • Number of events 9 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Renal and urinary disorders
URINARY RETENTION
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.3%
1/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Renal and urinary disorders
URINARY URGENCY
|
13.0%
3/23 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Reproductive system and breast disorders
IRREGULAR MENSTRUATION
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
ACNEIFORM RASH
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
BULLOUS DERMATITIS
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
CALLUS OF FOOT
|
4.3%
1/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
8.7%
2/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
HAIR COLOR CHANGE
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
22.7%
5/22 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
HYPOPIGMENTATION
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
MACULOPAPULAR RASH
|
8.7%
2/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
36.4%
8/22 • Number of events 17 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
RASH
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
TINEA PEDIS
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Vascular disorders
FLUSHING
|
26.1%
6/23 • Number of events 23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Vascular disorders
HOT FLASHES
|
39.1%
9/23 • Number of events 26 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Vascular disorders
HYPERTENSION
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
36.4%
8/22 • Number of events 9 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
1/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
18.2%
4/22 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Psychiatric disorders
Behaviour Disturbance
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Blood Bilirubin Increased
|
43.5%
10/23 • Number of events 55 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Cardiac disorders
Chest Pain
|
39.1%
9/23 • Number of events 21 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
Cold Sore
|
17.4%
4/23 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
Concentration Impairment
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Creatine Phosphokinase Increased
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Creatinine Increased
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Decreased Platelet Count
|
13.0%
3/23 • Number of events 10 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
22.7%
5/22 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Dental Caries
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
8.7%
2/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.4%
4/23 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Ear and labyrinth disorders
Ear And Labyrinth Disorders - Other, Impacted Cerumen
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Elevated Amylase
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Psychiatric disorders
Emotional Lability
|
21.7%
5/23 • Number of events 18 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
General disorders
Facial Pain
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
General disorders
Fever
|
4.3%
1/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Flatulence
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Buccal Cyst
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Dental Pain
|
8.7%
2/23 • Number of events 4 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Stomatitis
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
18.2%
4/22 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
13.0%
3/23 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
Infections And Infestations - Other, Covid-19
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
Infections And Infestations - Other, Gi Viral Infection
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Investigations - Other, Eosinophilia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Investigations - Other, Increased Mean Corpuscular Volume
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Investigations - Other, International Normalized Ration Increased
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
65.2%
15/23 • Number of events 82 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
General disorders
Localized Edema
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
Metabolism Other - Decreased Vitamin D
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Metabolism and nutrition disorders
Metbolism And Nutrition Disorders - Other, Hyperchloremia
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
17.4%
4/23 • Number of events 22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
3/23 • Number of events 11 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Neutrophil Count Decreased
|
21.7%
5/23 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
40.9%
9/22 • Number of events 20 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Pale Skin
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Psychiatric disorders
Panic Attack
|
34.8%
8/23 • Number of events 24 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Papulopustular Rash
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
Paresthesia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
4.3%
1/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Platelet Count Decreased
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
22.7%
5/22 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Psychiatric disorders
Psychiatric Disorders - Other, Mood Swings
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash Ezcematoid
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Renal and urinary disorders
Renal & Urinary Disorders - Other, Ketonuria
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
22.7%
5/22 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Scalp Lesion
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Cardiac disorders
Sinus Tachycardia
|
8.7%
2/23 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Disorders - Other, Achromotricia
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
13.6%
3/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders- Other, Erythema
|
8.7%
2/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
9.1%
2/22 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
|
4.3%
1/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin Blisters
|
43.5%
10/23 • Number of events 50 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
22.7%
5/22 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Psychiatric disorders
Suicidal Ideation
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Surgical and medical procedures
Surgical & Medical Procedures - Other, Dental Extractions
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Cardiac disorders
Tachycardia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
13.0%
3/23 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Surgical and medical procedures
Tooth Extraction
|
4.3%
1/23 • Number of events 3 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
Tooth Infection
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Gastrointestinal disorders
Toothache
|
26.1%
6/23 • Number of events 22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Total Protein Level Increased
|
34.8%
8/23 • Number of events 34 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Nervous system disorders
Tremor
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
Upper Respiratory Infection
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
18.2%
4/22 • Number of events 8 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Renal and urinary disorders
Urine Discoloration
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Urine White Blood Cell Increased
|
8.7%
2/23 • Number of events 6 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
Urobilinogen Increased
|
17.4%
4/23 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Immune system disorders
Vitamin D Deficiency
|
13.0%
3/23 • Number of events 5 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
White Blood Cell Count Decreased
|
65.2%
15/23 • Number of events 28 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
27.3%
6/22 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Investigations
White Blood Cell Count Increased
|
8.7%
2/23 • Number of events 7 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Infections and infestations
Wound Infection
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
0.00%
0/22 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
0.00%
0/23 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from start of dose (baseline) up to 2 years.
|
Additional Information
Karen Cole-Plourde, Program Director -NFCTC
The University of Alabama at Birmingham
Phone: (205) 514-1317
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place