Trial Outcomes & Findings for Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (NCT NCT03835533)
NCT ID: NCT03835533
Last Updated: 2024-04-12
Results Overview
An AE is any event that either occurs after the initiation of study drug, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, regardless of its relation to the drug. An SAE is any AE that suggests a significant hazard, contraindication, side effect, or untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded. The AE row includes all participants who experienced at least one AE, including SAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
For AEs, from initiation of study drug through 100 days after last dose, up to 24 months. For SAEs, from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months.
Results posted on
2024-04-12
Participant Flow
Participant milestones
| Measure |
Cohort A: NKTR-214 + Nivolumab
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
14
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
11
|
Reasons for withdrawal
| Measure |
Cohort A: NKTR-214 + Nivolumab
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
Overall Study
Death
|
5
|
10
|
9
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Patients were excluded from the calculation if there was not a sufficient quantity of blood in the patient's collection tube to obtain a result.
Baseline characteristics by cohort
| Measure |
Cohort A: NKTR-214 + Nivolumab
n=14 Participants
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
n=15 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
n=14 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=43 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=14 Participants
|
6 Participants
n=15 Participants
|
4 Participants
n=14 Participants
|
19 Participants
n=43 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=14 Participants
|
9 Participants
n=15 Participants
|
10 Participants
n=14 Participants
|
24 Participants
n=43 Participants
|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 6.9 • n=14 Participants
|
69.7 years
STANDARD_DEVIATION 10.3 • n=15 Participants
|
71.4 years
STANDARD_DEVIATION 9.3 • n=14 Participants
|
68.4 years
STANDARD_DEVIATION 9.3 • n=43 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=14 Participants
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
43 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
5 Participants
n=15 Participants
|
2 Participants
n=14 Participants
|
7 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=14 Participants
|
10 Participants
n=15 Participants
|
12 Participants
n=14 Participants
|
36 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=43 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=43 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=14 Participants
|
3 Participants
n=15 Participants
|
2 Participants
n=14 Participants
|
5 Participants
n=43 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
12 Participants
n=14 Participants
|
8 Participants
n=15 Participants
|
11 Participants
n=14 Participants
|
31 Participants
n=43 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=14 Participants
|
4 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
5 Participants
n=43 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=14 Participants
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
43 Participants
n=43 Participants
|
|
ECOG Performance Score at Screening
0
|
8 Participants
n=14 Participants
|
8 Participants
n=15 Participants
|
10 Participants
n=14 Participants
|
26 Participants
n=43 Participants
|
|
ECOG Performance Score at Screening
1
|
5 Participants
n=14 Participants
|
7 Participants
n=15 Participants
|
4 Participants
n=14 Participants
|
16 Participants
n=43 Participants
|
|
ECOG Performance Score at Screening
Missing
|
1 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=43 Participants
|
|
Cancer Stage at Initial Diagnosis
Stage 1
|
2 Participants
n=14 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
3 Participants
n=43 Participants
|
|
Cancer Stage at Initial Diagnosis
Stage 2
|
2 Participants
n=14 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
5 Participants
n=43 Participants
|
|
Cancer Stage at Initial Diagnosis
Stage 3
|
2 Participants
n=14 Participants
|
2 Participants
n=15 Participants
|
4 Participants
n=14 Participants
|
8 Participants
n=43 Participants
|
|
Cancer Stage at Initial Diagnosis
Stage 4
|
8 Participants
n=14 Participants
|
8 Participants
n=15 Participants
|
8 Participants
n=14 Participants
|
24 Participants
n=43 Participants
|
|
Cancer Stage at Initial Diagnosis
Unknown
|
0 Participants
n=14 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
3 Participants
n=43 Participants
|
|
Prostate-Specific Antigen (PSA) (ng/mL) at Baseline
|
25.3 ng/mL
n=14 Participants
|
37.1 ng/mL
n=15 Participants
|
43.0 ng/mL
n=14 Participants
|
32.7 ng/mL
n=43 Participants
|
|
Circulating Tumor Cells (CTC) value (cells/7.5 mL of blood) at Baseline
|
4.5 cells/7.5 mL of blood
n=10 Participants • Patients were excluded from the calculation if there was not a sufficient quantity of blood in the patient's collection tube to obtain a result.
|
13.0 cells/7.5 mL of blood
n=13 Participants • Patients were excluded from the calculation if there was not a sufficient quantity of blood in the patient's collection tube to obtain a result.
|
5.5 cells/7.5 mL of blood
n=14 Participants • Patients were excluded from the calculation if there was not a sufficient quantity of blood in the patient's collection tube to obtain a result.
|
5.0 cells/7.5 mL of blood
n=37 Participants • Patients were excluded from the calculation if there was not a sufficient quantity of blood in the patient's collection tube to obtain a result.
|
PRIMARY outcome
Timeframe: For AEs, from initiation of study drug through 100 days after last dose, up to 24 months. For SAEs, from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months.Population: The evaluable population is defined as all participants in a cohort who received at least one dose of any component of the combination study intervention.
An AE is any event that either occurs after the initiation of study drug, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, regardless of its relation to the drug. An SAE is any AE that suggests a significant hazard, contraindication, side effect, or untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded. The AE row includes all participants who experienced at least one AE, including SAEs.
Outcome measures
| Measure |
Cohort A: NKTR-214 + Nivolumab
n=14 Participants
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
n=15 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
n=14 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Adverse Events (AEs)
|
14 Participants
|
15 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Serious Adverse Events (SAEs)
|
7 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 20 monthsPopulation: The evaluable population is defined as all participants in a cohort who received at least one dose of any component of the combination study intervention.
CRR is a composite endpoint where response is defined as a participant meeting at least one of the following: 1. circulating tumor cells (CTC) change from unfavorable (≥ 5 cells/7.5 mL of blood) to favorable (\<= 4 cells/7.5 mL of blood); 2. ≥ 50% reduction in Prostate-Specific Antigen (PSA) from baseline, with a repeat assessment confirming the results at least 3 weeks later; 3. Per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, a complete response (CR; disappearance of all target and non-target lesions) or partial response (PR; \>=30% decrease in the sum of the longest diameter of target lesions). A repeat tumor assessment must confirm the CR/PR results at least 3 weeks later.
Outcome measures
| Measure |
Cohort A: NKTR-214 + Nivolumab
n=14 Participants
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
n=15 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
n=14 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
Composite Response Rate (CRR)
|
1 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 20 monthsPopulation: The evaluable population is defined as all participants in a cohort who received at least one dose of any component of the combination study intervention.
Per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, a complete response (CR) is defined as disappearance of all target and non-target lesions and a partial response (PR) as a \>=30% decrease in the sum of the longest diameter of target lesions. A repeat tumor assessment must confirm the CR/PR results at least 3 weeks later. DCR = CR + PR + stable disease lasting at least 6 months.
Outcome measures
| Measure |
Cohort A: NKTR-214 + Nivolumab
n=14 Participants
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
n=15 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
n=14 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
Disease Control Rate (DCR)
|
2 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 20 monthsPopulation: The evaluable population is defined as all participants in a cohort who received at least one dose of any component of the combination study intervention.
Defined as time from initiation of study intervention to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST) version 1.1, radiographic progression is defined using as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new non-bone lesions, or at least 2 new bone lesions relative to the first post-treatment scan that are confirmed on a subsequent scan. rPFS and confidence intervals were estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A: NKTR-214 + Nivolumab
n=14 Participants
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
n=15 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
n=14 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
Radiographic Progression-free Survival (rPFS)
|
2.8 months
Interval 2.0 to 7.26
|
7.5 months
Interval 3.52 to 10.48
|
3.2 months
Interval 2.66 to 10.28
|
SECONDARY outcome
Timeframe: From initiation of study drug until death due to any cause, up to 2.5 yearsPopulation: The evaluable population is defined as all participants in a cohort who received at least one dose of any component of the combination study intervention.
Defined as the time from initiation of study invention until death due to any cause. OS and confidence intervals were estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A: NKTR-214 + Nivolumab
n=14 Participants
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
n=15 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
n=14 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 9.04 to
The median and upper confidence limit is not estimable due to an insufficient number of participants with an event
|
20.6 months
Interval 5.65 to 27.5
|
17.3 months
Interval 3.48 to
The median and upper confidence limit is not estimable due to an insufficient number of participants with an event
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: The evaluable population is defined as all participants in a cohort who received at least one dose of any component of the combination study intervention.
Defined as the overall survival probability at 12 months, calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A: NKTR-214 + Nivolumab
n=14 Participants
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
n=15 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
n=14 Participants
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
Overall Survival (OS) at 12 Months
|
0.579 probability
Interval 0.26 to 0.801
|
0.525 probability
Interval 0.252 to 0.74
|
0.524 probability
Interval 0.227 to 0.754
|
Adverse Events
Cohort A: NKTR-214 + Nivolumab
Serious events: 7 serious events
Other events: 13 other events
Deaths: 5 deaths
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
Serious events: 4 serious events
Other events: 15 other events
Deaths: 10 deaths
Cohort C: CDX-301 + INO-5151 + Nivolumab
Serious events: 5 serious events
Other events: 13 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Cohort A: NKTR-214 + Nivolumab
n=14 participants at risk
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
n=15 participants at risk
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
n=14 participants at risk
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
Infections and infestations
Endocarditis
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
COVID-19
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Endocrine disorders
Hyperthyroidism
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Immune system disorders
Cytokine release syndrome
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
Other adverse events
| Measure |
Cohort A: NKTR-214 + Nivolumab
n=14 participants at risk
NKTR-214 (Cohort A): NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
|
Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
n=15 participants at risk
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
Stereotactic body radiation therapy (SBRT) (Cohort B): Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
Poly-ICLC (Cohort B): Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
|
Cohort C: CDX-301 + INO-5151 + Nivolumab
n=14 participants at risk
Nivolumab (Cohort A, B and C): Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
CDX-301 (Cohort B and C): CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
INO-5151 (Cohort C): INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
Cellectra 2000: Electroporation device
|
|---|---|---|---|
|
General disorders
Fatigue
|
42.9%
6/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
35.7%
5/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Pyrexia
|
42.9%
6/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Chills
|
28.6%
4/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Asthenia
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Influenza like illness
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Injection site reaction
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Chest pain
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Generalised oedema
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Injection site discomfort
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Injection site irritation
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Injection site pain
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Pain
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
General disorders
Tenderness
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.4%
3/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
26.7%
4/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
26.7%
4/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.7%
5/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
33.3%
5/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
26.7%
4/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
26.7%
4/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
21.4%
3/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
20.0%
3/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Aspartate aminotransferase increased
|
35.7%
5/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
26.7%
4/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
4/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Blood creatinine increased
|
28.6%
4/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Lymphocyte count decreased
|
35.7%
5/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Weight decreased
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
White blood cell count decreased
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Platelet count decreased
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Body temperature increased
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
Troponin I increased
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Investigations
White blood cell count increased
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.7%
5/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
20.0%
3/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
21.4%
3/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
21.4%
3/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
20.0%
3/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
21.4%
3/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
28.6%
4/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.9%
6/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
4/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.4%
3/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
4/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
40.0%
6/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
28.6%
4/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
21.4%
3/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Restless legs syndrome
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Vascular disorders
Flushing
|
21.4%
3/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Vascular disorders
Hot flush
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Oral herpes
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Rash pustular
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Endocrine disorders
Hypothyroidism
|
28.6%
4/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Endocrine disorders
Hyperthyroidism
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Renal and urinary disorders
Dysuria
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Renal and urinary disorders
Haematuria
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Renal and urinary disorders
Haemoglobinuria
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
20.0%
3/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
13.3%
2/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Eye disorders
Vision blurred
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Eye disorders
Blepharitis
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Eye disorders
Eyelid function disorder
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Eye disorders
Hypermetropia
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Eye disorders
Photopsia
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Eye disorders
Visual impairment
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Immune system disorders
Hypersensitivity
|
14.3%
2/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
6.7%
1/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.1%
1/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/15 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
0.00%
0/14 • Adverse events (AEs) were collected from initiation of study drug through 100 days after last dose, up to 24 months. Serious adverse events (SAEs) were collected from signing informed consent (prior to Screening) through 100 days after last dose, up to 24 months. All-cause mortality was collected from initiation of study drug, up to 2.5 years.
Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Trial Site and/or Co-Principal Investigators may publish or present Study Data and other results of the Study from the Trial Site individually upon the first to occur of: (i) twelve (12) months after conclusion, abandonment, or termination of the Study at all Affiliated Research Institutions, or (ii) after Parker Institute for Cancer Immunotherapy \[PICI\] confirms in writing there will not be a multi-site Study publication.
- Publication restrictions are in place
Restriction type: OTHER