Trial Outcomes & Findings for DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission (NCT NCT02166905)
NCT ID: NCT02166905
Last Updated: 2023-02-24
Results Overview
To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 300mg, number of Participants with Dose Limiting Toxicities is reported
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
28 days
Results posted on
2023-02-24
Participant Flow
Participant milestones
| Measure |
Phase I (CDX-1401, Poly ICLC)
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles
|
Phase IIb arm1 (CDX-1401, Poly ICLC, IDO1 Without Inhibitor INCB024360)
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
|
Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles
|
Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. )
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
16
|
15
|
2
|
|
Overall Study
COMPLETED
|
6
|
16
|
15
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I (CDX-1401, Poly ICLC)
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles
|
Phase IIb arm1 (CDX-1401, Poly ICLC, IDO1 Without Inhibitor INCB024360)
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
|
Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles
|
Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. )
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
Baseline characteristics by cohort
| Measure |
Phase I (CDX-1401, Poly ICLC)
n=6 Participants
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles
|
Phase IIb arm1 (CDX-1401, Poly ICLC, IDO1 Without Inhibitor INCB024360)
n=16 Participants
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
|
Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)
n=15 Participants
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles
|
Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. )
n=2 Participants
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 12 • n=5 Participants
|
65 years
STANDARD_DEVIATION 10 • n=7 Participants
|
63 years
STANDARD_DEVIATION 10 • n=5 Participants
|
63 years
STANDARD_DEVIATION 8 • n=4 Participants
|
64 years
STANDARD_DEVIATION 10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 daysTo determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 300mg, number of Participants with Dose Limiting Toxicities is reported
Outcome measures
| Measure |
Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )
n=6 Participants
Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose (300mg ) of BID orally
|
Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles
|
Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. )
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off
|
Phase IIb Arm 3 (Exploratory Cohort )
4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC
|
|---|---|---|---|---|
|
To Determine the Safety and Evaluate Toxicity of Fixed Doses for Phase I Patients
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Progression free survival rates (proportion) at 6 months are reported.
Percentage of Participants with Progression Free Survival Using irRC Criteria for Phase II Patients are reported. irRC criteria disease progression is defined as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.
Outcome measures
| Measure |
Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )
n=16 Participants
Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose (300mg ) of BID orally
|
Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)
n=15 Participants
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles
|
Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. )
n=2 Participants
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off
|
Phase IIb Arm 3 (Exploratory Cohort )
4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) Based on Immune Related Response Criteria (irRC) for Phase II Patients
|
0.78 Proportion of participants w/o Progress
Interval 0.52 to 0.91
|
0.54 Proportion of participants w/o Progress
Interval 0.29 to 0.73
|
0.50 Proportion of participants w/o Progress
Interval 0.02 to 0.88
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsAll patients enrolled in this study will be eligible for the analysis of toxicity. The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson).
Outcome measures
| Measure |
Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )
n=6 Participants
Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose (300mg ) of BID orally
|
Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)
n=16 Participants
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles
|
Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. )
n=15 Participants
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.
Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles
\+ Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off
|
Phase IIb Arm 3 (Exploratory Cohort )
n=2 Participants
4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC
|
|---|---|---|---|---|
|
To Evaluate Toxicity as Defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Serious Adverse Events
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
|
To Evaluate Toxicity as Defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Other Adverse Events
|
6 participants
|
14 participants
|
15 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: There were 0 patients with this information analyzed. All efforts were made to retrieve data.
Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: There were 0 patients with this information analyzed. All efforts were made to retrieve data.
Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: There were 0 patients with this information analyzed. All efforts were made to retrieve data.
Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: There were 0 patients with this information analyzed. All efforts were made to retrieve data.
Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II 2a (CDX-1401, Poly ICLC)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Phase II 2b (CDX-1401, Poly ICLC With INCB024360)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 3 deaths
Phase II 3 (Exploratory Cohort)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )
n=6 participants at risk
Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally
|
Phase II 2a (CDX-1401, Poly ICLC)
n=16 participants at risk
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection
Epacadostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Poly ICLC: Given SC
|
Phase II 2b (CDX-1401, Poly ICLC With INCB024360)
n=15 participants at risk
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection
Epacadostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Poly ICLC: Given SC
|
Phase II 3 (Exploratory Cohort)
n=2 participants at risk
4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Cardiac death
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
Other adverse events
| Measure |
Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )
n=6 participants at risk
Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally
|
Phase II 2a (CDX-1401, Poly ICLC)
n=16 participants at risk
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection
Epacadostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Poly ICLC: Given SC
|
Phase II 2b (CDX-1401, Poly ICLC With INCB024360)
n=15 participants at risk
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection
Epacadostat: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Poly ICLC: Given SC
|
Phase II 3 (Exploratory Cohort)
n=2 participants at risk
4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
18.8%
3/16 • Number of events 3 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Infections and infestations
Onychomycosis
|
33.3%
2/6 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Injury, poisoning and procedural complications
Splinter
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
50.0%
1/2 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
12.5%
2/16 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
12.5%
2/16 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
50.0%
1/2 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
50.0%
1/2 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
12.5%
2/16 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
12.5%
2/16 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
13.3%
2/15 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 4 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
18.8%
3/16 • Number of events 3 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
20.0%
3/15 • Number of events 4 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
50.0%
1/2 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
13.3%
2/15 • Number of events 4 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Asthenia
|
33.3%
2/6 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Chills
|
50.0%
3/6 • Number of events 5 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
13.3%
2/15 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Early satiety
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 4 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
18.8%
3/16 • Number of events 3 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
40.0%
6/15 • Number of events 8 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
25.0%
4/16 • Number of events 5 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
40.0%
6/15 • Number of events 7 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
100.0%
2/2 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Injection site discolouration
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Injection site discomfort
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Injection site erythema
|
100.0%
6/6 • Number of events 11 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
37.5%
6/16 • Number of events 6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
46.7%
7/15 • Number of events 7 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Injection site nodule
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Injection site pain
|
66.7%
4/6 • Number of events 11 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
25.0%
4/16 • Number of events 5 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
26.7%
4/15 • Number of events 4 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
12.5%
2/16 • Number of events 7 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
26.7%
4/15 • Number of events 6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
50.0%
1/2 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Injection site swelling
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Oedema
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 3 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
12.5%
2/16 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
12.5%
2/16 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Product Issues
Thrombosis in device
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Psychiatric disorders
Mental status changes
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 3 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
33.3%
2/6 • Number of events 2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/15 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.2%
1/16 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
26.7%
4/15 • Number of events 5 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 3 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
6.7%
1/15 • Number of events 1 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/16 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
13.3%
2/15 • Number of events 3 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
0.00%
0/2 • Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place