Trial Outcomes & Findings for Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors (NCT NCT04616534)
NCT ID: NCT04616534
Last Updated: 2026-07-31
Results Overview
Radiological response will be assessed with Response Evaluation Criteria in Solid Tumors 1.1 criteria and will be portrayed as the percentage of subjects with a complete response (CR) and partial response (PR).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
ORR was assessed from the time of the first patient on study (June 2021) through the last patient off study (October 2024). ORR was calculated for a median of 103 days, ranging from 30 - 312 days.
Results posted on
2026-07-31
Participant Flow
The study did not progress into the dose expansion cohort and therefore no participants were enrolled into this arm.
Participant milestones
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Expansion Cohort
Participants were not enrolled into the dose expansion cohort due to the study not progressing into the next phase. The recommended phase 2 dose was not found.
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Overall Study
STARTED
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3
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2
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3
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3
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3
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0
|
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Overall Study
COMPLETED
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3
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2
|
3
|
3
|
3
|
0
|
|
Overall Study
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 Participants
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 Participants
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
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Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
4 Participants
n=22 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
10 Participants
n=22 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
10 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
4 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
14 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
11 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
14 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024) (3 years and 4 months). Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.The toxicity of the combination of gemcitabine plus elimusertib will be assessed with Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0 criteria. The safety and tolerability were evaluated using the number of treatment-related adverse events.
Outcome measures
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 Participants
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 Participants
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
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Total Study Population
Participants have been grouped from all cohorts into this one cumulative cohort, as PFS could not be calculated per cohort.
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|---|---|---|---|---|---|---|
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Number of Patients on Treatment With Related Adverse Events
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: The MTD was evaluated during the dose-escalation phase, occurring from the first patient on treatment (Jun '21) through the last patient's last dose (Sep '24) (3 years and 3 months). MTD was evaluated for a median of 58.5 days, ranging 28 - 285 days.A conventional algorithm (3+3 design) will be used to identify the MTD, escalating on zero of three or one of six dose-limiting toxicities (DLTs), and de-escalating if two DLTs are encountered. The MTD will be the highest dose level at which zero of three or one of six subjects experience a DLT. The MTD was not reached due to toxicity experienced during cycle 1.
Outcome measures
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 Participants
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 Participants
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Total Study Population
Participants have been grouped from all cohorts into this one cumulative cohort, as PFS could not be calculated per cohort.
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|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
NA mg
No safe dose was found and the trial was stopped early for toxicity.
|
NA mg
No safe dose was found and the trial was stopped early for toxicity.
|
NA mg
No safe dose was found and the trial was stopped early for toxicity.
|
NA mg
No safe dose was found and the trial was stopped early for toxicity.
|
NA mg
No safe dose was found and the trial was stopped early for toxicity.
|
—
|
PRIMARY outcome
Timeframe: ORR was assessed from the time of the first patient on study (June 2021) through the last patient off study (October 2024). ORR was calculated for a median of 103 days, ranging from 30 - 312 days.Radiological response will be assessed with Response Evaluation Criteria in Solid Tumors 1.1 criteria and will be portrayed as the percentage of subjects with a complete response (CR) and partial response (PR).
Outcome measures
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 Participants
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 Participants
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Total Study Population
Participants have been grouped from all cohorts into this one cumulative cohort, as PFS could not be calculated per cohort.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
33.3 percent of participants
|
0 percent of participants
|
0 percent of participants
|
0 percent of participants
|
0 percent of participants
|
—
|
PRIMARY outcome
Timeframe: Duration of response was assessed from the time of the first patient on treatment (June 2021) through the last patient off study (October 2024). Duration of response was calculated for a median of 103 days, ranging from 30 - 312 days.Population: Only one participant showed a response to study treatment. This participant was in Dose Level 1. All participants were assessed for duration of response.
Outcome measures
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 Participants
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 Participants
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Total Study Population
Participants have been grouped from all cohorts into this one cumulative cohort, as PFS could not be calculated per cohort.
|
|---|---|---|---|---|---|---|
|
Duration of Response
|
0.78 months
Interval 0.0 to 2.33
|
0 months
Interval 0.0 to 0.0
|
0 months
Interval 0.0 to 0.0
|
0 months
Interval 0.0 to 0.0
|
0 months
Interval 0.0 to 0.0
|
—
|
PRIMARY outcome
Timeframe: PFS was evaluated from the first patient on study (Jun '21) through the last patient's death or date of progressive disease (Sep '24) (3 years and 3 months). PFS was calculated for a median of 90 days, ranging 25 - 286 days.Population: PFS could not be calculated for each individual cohort due to insufficient number of participants with events. Therefore, PFS has been reported for the entire study population.
Outcome measures
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 Participants
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 Participants
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Total Study Population
n=14 Participants
Participants have been grouped from all cohorts into this one cumulative cohort, as PFS could not be calculated per cohort.
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
NA months
PFS could not be calculated for each individual cohort due to the small sample size.
|
NA months
PFS could not be calculated for each individual cohort due to the small sample size.
|
NA months
PFS could not be calculated for each individual cohort due to the small sample size.
|
NA months
PFS could not be calculated for each individual cohort due to the small sample size.
|
NA months
PFS could not be calculated for each individual cohort due to the small sample size.
|
2.89 months
Interval 1.08 to
Upper limit not reached.
|
PRIMARY outcome
Timeframe: OS was calculated for a median of 103 days, ranging from 30 - 312 days.Overall survival (OS) was evaluated from the first patient on study (June 2021) through the last patient's death or off study date (October 2024).
Outcome measures
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 Participants
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 Participants
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Total Study Population
Participants have been grouped from all cohorts into this one cumulative cohort, as PFS could not be calculated per cohort.
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
102.7 days
Interval 53.0 to 173.0
|
46.0 days
Interval 30.0 to 62.0
|
111.0 days
Interval 34.0 to 165.0
|
161.0 days
Interval 41.0 to 312.0
|
161.7 days
Interval 91.0 to 279.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 of dose-escalation phase (first patient's day 1, June 2021, to last patient's day 1, December 2023) equaling the total collection time of 2 year and 6 months. PK samples for collected on a single day for each participant.Population: No samples were collected in Dose Escalation Level B4 and Dose Escalation Level 1ESC cohorts. Therefore, no data has been entered for these cohorts.
Individual PK parameters will be estimated for the maximum concentration (Cmax), as feasible with non-compartmental methods. The PK variables will be tabulated, and descriptive statistics (e.g., geometric means and coefficients of variation) will be calculated for each dose level. PK parameters will be reported descriptively.
Outcome measures
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 Participants
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 Participants
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Total Study Population
Participants have been grouped from all cohorts into this one cumulative cohort, as PFS could not be calculated per cohort.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Profile of Elimusertib in Combination With Gemcitabine
|
332 µg/L
Standard Deviation 1.16
|
685 µg/L
Standard Deviation 2.13
|
—
|
464 µg/L
Standard Deviation 1.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 8 of cycle 1 dose-escalation (first patient's day 1, June 2021, to last patient's day 8, December 2023) equaling the total collection time of 2 year and 6 months. Samples were collected on two days for each participant.Population: The trial ended early due to toxicity. No gem PK analyses were run, as none of the samples were analyzed for this assessment prior to study termination and all samples have been destroyed.
The CDA phenotype will be correlated with gemcitabine half-life, AUC and the dFdU/gemcitabine metabolic ratio.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-treatment to time of disease progression, assessed up to 1 year in the dose expansion cohortPopulation: The trial ended early due to toxicity. The Dose Expansion Cohort was not initiated and no participants could be assessed for this Outcome Measure.
Will be defined according to formation of RAD51 foci. Will also be evaluated in relation to the clinical outcomes of ORR and PFS time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-treatment to time of disease progression, assessed up to 1 year in the dose expansion cohortPopulation: The trial ended early due to toxicity. The Dose Expansion Cohort was not initiated and no participants could be assessed for this Outcome Measure.
Will be defined by the expression of pATR and pCHK1. Will also be evaluated in relation to the clinical outcomes of ORR and PFS time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-treatment and on-treatment in the dose expansion cohortPopulation: The trial ended early due to toxicity. The Dose Expansion Cohort was not initiated and no participants could be assessed for this Outcome Measure.
Changes in immunohistochemical markers of DNA damage, gamma-H2AX and phosphorylated (p)NBS1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-treatment to time of disease progression, assessed up to 1 year in the dose expansion cohortPopulation: The trial ended early due to toxicity. The Dose Expansion Cohort was not initiated and no participants could be assessed for this Outcome Measure.
DNA fiber assays will be used to assess whether gemcitabine/elimusertib treatment converts a cancer with stable replication forks to one with unstable replication forks. Will also be evaluated in relation to the clinical outcomes of ORR and PFS time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-treatment to time of disease progression, assessed up to 1 year in the dose expansion cohort.Population: The trial ended early due to toxicity. The Dose Expansion Cohort was not initiated and no participants could be assessed for this Outcome Measure.
Will be defined at the gene expression and protein levels for phosphorylated (p)KAP1, pRPA32, cyclin E and MYC. Will also be evaluated in relation to the clinical outcomes of ORR and PFS time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 of dose-escalation phase (first patient's day 1, June 2021, to last patient's day 1, December 2023) equaling the total collection time of 2 year and 6 months. PK samples for collected on a single day for each participant.Population: No samples were collected in Dose Escalation Level B4 and Dose Escalation Level 1ESC cohorts. Therefore, no data has been entered for these cohorts.
Individual PK parameters will be estimated for the area under the concentration-time curve (AUC), as feasible with non-compartmental methods. The PK variables will be tabulated, and descriptive statistics (e.g., geometric means and coefficients of variation) will be calculated for each dose level. PK parameters will be reported descriptively.
Outcome measures
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 Participants
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 Participants
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 Participants
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Total Study Population
Participants have been grouped from all cohorts into this one cumulative cohort, as PFS could not be calculated per cohort.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Profile of Elimusertib in Combination With Gemcitabine
|
1.36 mg/L•h
Standard Deviation 1.13
|
2.03 mg/L•h
Standard Deviation 1.48
|
—
|
1.61 mg/L•h
Standard Deviation 1.32
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of dose-escalation phase (first patient's day 1, June 2021, to last patient's day 1, December 2023) equaling the total collection time of 2 year and 6 months. PK samples for collected on a single day for each participant.Population: The trial ended early due to toxicity. Samples were not analyzed for these assessments prior to early study termination at which point all samples destroyed and no data collected.
Individual PK parameters will be estimated for the half-life (t1/2), apparent clearance (Cl/F) and apparent volume of distribution (V/F), as feasible with non-compartmental methods. The PK variables will be tabulated, and descriptive statistics (e.g., geometric means and coefficients of variation) will be calculated for each dose level. PK parameters will be reported descriptively.
Outcome measures
Outcome data not reported
Adverse Events
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 participants at risk
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 participants at risk
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 participants at risk
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 participants at risk
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=3 participants at risk
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
|---|---|---|---|---|---|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Fever
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
2/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Peritoneal infection
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
2/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
Other adverse events
| Measure |
Dose Escalation Level 1: 250 MG/M2 GEMCITABINE D1, 8 + 40 MG BAY1895344 (ELIMUSERTIB) BID D1-3,8-10
n=3 participants at risk
Patients in Dose Escalation Level 1 received 250 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 40mg elimusertib PO BID on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B1: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=2 participants at risk
Patients in Dose Escalation Level B1 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B4: 100MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 participants at risk
Patients in Dose Escalation Level B4 received 100 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level B6: 175MG/M2 GEMCITABINE D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) QD D2-3, 9-10
n=3 participants at risk
Patients in Dose Escalation Level B6 received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO QD on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
Dose Escalation Level 1ESC: 175MG/M2 GEM D1, 8 + 20MG BAY 1895344 (ELIMUSERTIB) BID D2-3, 9-10
n=3 participants at risk
Patients in Dose Escalation Level 1ESC received 175 mg/m2 gemcitabine IV over 30 minutes on days 1 and 8 and 20mg elimusertib PO BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial. PK samples were collected Days 1, 2, and 8 of Cycle 1. Streck cfDNA tube collections were done at Pre-Study visit.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
2/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
2/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Musculoskeletal and connective tissue disorders
body aches
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Skin and subcutaneous tissue disorders
Cellulitis-left ankle
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Fever
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Mucositis oral
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
2/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
100.0%
3/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Cardiac disorders
premature atrial contraction/bigeminy)
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
66.7%
2/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
50.0%
1/2 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
0.00%
0/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
33.3%
1/3 • Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, and within 30 days of the last dose of treatment. Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024), equaling a collection time of 3 years and 4 months. Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60